Receipt of human papillomavirus vaccine among privately insured adult women in a U.S. Midwestern Health Maintenance Organization.

OBJECTIVES: To describe human papillomavirus (HPV) vaccine coverage among adult privately insured women including variation in coverage by race/ethnicity. METHODS: This cross-sectional, observational study included women 18-26 years of age with continuous enrollment in a U.S. Midwestern health insurance plan and at least one visit to a plan affiliated practice. Vaccination data came from insurance claims and the electronic medical record. Primary outcomes were: receipt of at least 1 HPV vaccine (HPV1) and completion of the 3-dose HPV vaccine series (HPV3). Coverage was described for the entire cohort and stratified by race/ethnicity. For a subset of women, automated data was compared to personal recall. RESULTS: As of June 2010, among 2546 privately insured women 18-26 years, 72.7% had received their first HPV vaccine and 57.9% completed the 3-dose series. Compared to white women, African American and Asian women had significantly lower coverage for HPV1 and HPV3. There was 94.5% (95% CI: 88.5-100%) agreement between personal recall and claims/EMR for receiving HPV1. CONCLUSIONS: In this cohort of privately insured women, a majority received HPV1 and more than half completed the 3-dose vaccine series. Marked disparities in receipt of HPV vaccine by race/ethnicity were observed.

Patient characteristics associated with medication adherence.

OBJECTIVE: Despite evidence indicating therapeutic benefit for adhering to a prescribed regimen, many patients do not take their medications as prescribed. Non-adherence often leads to morbidity and to higher health care costs. The objective of the study was to assess patient characteristics associated with medication adherence across eight diseases. DESIGN: Retrospective data from a repository within an integrated health system was used to identify patients ≥18 years of age with ICD-9-CM codes for primary or secondary diagnoses for any of eight conditions (depression, hypertension, hyperlipidemia, diabetes, asthma or chronic obstructive pulmonary disease, multiple sclerosis, cancer, or osteoporosis). Electronic pharmacy data was then obtained for 128 medications used for treatment. METHODS: Medication possession ratios (MPR) were calculated for those with one condition and one drug (n=15,334) and then for the total population having any of the eight diseases (n=31,636). The proportion of patients adherent (MPR ≥80%) was summarized by patient and living-area (census) characteristics. Bivariate associations between drug adherence and patient characteristics (age, sex, race, education, and comorbidity) were tested using contingency tables and chi-square tests. Logistic regression analysis examined predictors of adherence from patient and living area characteristics. RESULTS: Medication adherence for those with one condition was higher in males, Caucasians, older patients, and those living in areas with higher education rates and higher income. In the total population, adherence increased with lower comorbidity and increased number of medications. Substantial variation in adherence was found by condition with the lowest adherence for diabetes (51%) and asthma (33%). CONCLUSIONS: The expectation of high adherence due to a covered pharmacy benefit, and to enhanced medication access did not hold. Differences in medication adherence were found across condition and by patient characteristics. Great room for improvement remains, specifically for diabetes and asthma.

Influenza and pertussis vaccination coverage among privately insured women of reproductive age.

An increasing number of vaccines are now designated as maternal vaccines, recommended prior to, during, or immediately following pregnancy. The influenza and pertussis (Tdap) vaccines have the potential to improve the health of women and their offspring. Among privately insured women of reproductive age, goals of this study were to describe influenza and Tdap vaccination coverage and to explore variation in coverage by age and race/ethnicity. This cross-sectional, observational study included women 18-44 years of age with continuous enrollment from 1 January 2007-31 March 2011 in a single, Midwestern health insurance plan and at least one visit to a plan affiliated practice. Data on vaccine coverage came from insurance claims, supplemented by electronic medical record data. Primary outcomes were: receipt of Tdap ever, receipt of Tdap or Tetanus vaccination (Td) in the past 10 years, and receipt of influenza vaccination during the 2010-2011 influenza season. Coverage was compared by race/ethnicity. Among 12,657 women with continuous private insurance, 45.5 % had received Tdap ever, 82.5 % had received Td or Tdap in the past 10 years, and 39.8 % received the influenza vaccine in the 2010-2011 season. Marked disparities in influenza vaccination coverage by race/ethnicity were observed, only 30.0 % of African American women received influenza vaccine compared to 40.7 % of white, non-Hispanic women (p < .0001). Among insured women of reproductive age, there is a need for interventions to increase Tdap and influenza vaccination uptake. Further research is needed to understand and address disparities in influenza vaccination coverage in this population.

Barriers in identification and referral to genetic counseling for familial cancer risk: the perspective of genetic service providers.

The purpose of this study was to obtain genetic counselors' perspectives about the identification of appropriate patients and barriers to referral of high-risk patients for cancer genetic counseling services. Genetic service providers from eight integrated health systems were surveyed. Data analysis included descriptive statistics. Twenty-eight of 40 potential participants responded (70%). Referrals for familial cancer risk assessment overwhelmingly came from providers (89%); only 10% were self-referrals. Use of guidelines to assist providers with referral was reported by 46% of the respondents. Genetic service providers perceived patient barriers to seeking genetic counseling after referral included: risk evaluation viewed as a non-priority (72%), concerns about impact on insurability (52%), distance to appointments (48%), lack of insurance (44%), lack of patient/provider knowledge about the value of genetic counseling (36%), discouragement by family members (28%), and fear (20%). The best approaches suggested by respondents to increase appropriate referrals were attending meetings and giving presentations to oncologists, surgeons, primary care and gynecologists. The genetic service providers reported several barriers to the referral and use of genetic counseling. This finding is consistent with current literature from the providers' perspective. Our survey adds the genetic service providers' perspective and identifies areas of opportunity for further research and intervention as few of the perceived barriers are being addressed through current educational efforts.

A randomized clinical trial evaluating online interventions to improve fruit and vegetable consumption.

OBJECTIVES: We assessed change in fruit and vegetable intake in a population-based sample, comparing an online untailored program (arm 1) with a tailored behavioral intervention (arm 2) and with a tailored behavioral intervention plus motivational interviewing-based counseling via e-mail (arm 3). METHODS: We conducted a randomized controlled intervention trial, enrolling members aged 21 to 65 years from 5 health plans in Seattle, Washington; Denver, Colorado; Minneapolis, Minnesota; Detroit, Michigan; and Atlanta, Georgia. Participants reported fruit and vegetable intake at baseline and at 3, 6, and 12 months. We assessed mean change in fruit and vegetable servings per day at 12 months after baseline, using a validated self-report fruit and vegetable food frequency questionnaire. RESULTS: Of 2540 trial participants, 80% were followed up at 12 months. Overall baseline mean fruit and vegetable intake was 4.4 servings per day. Average servings increased by more than 2 servings across all study arms (P<.001), with the greatest increase (+2.8 servings) among participants of arm 3 (P=.05, compared with control). Overall program satisfaction was high. CONCLUSIONS: This online nutritional intervention was well received, convenient, easy to disseminate, and associated with sustained dietary change. Such programs have promise as population-based dietary interventions.

Engagement and retention: measuring breadth and depth of participant use of an online intervention.

BACKGROUND: The Internet provides us with tools (user metrics or paradata) to evaluate how users interact with online interventions. Analysis of these paradata can lead to design improvements. OBJECTIVE: The objective was to explore the qualities of online participant engagement in an online intervention. We analyzed the paradata in a randomized controlled trial of alternative versions of an online intervention designed to promote consumption of fruit and vegetables. METHODS: Volunteers were randomized to 1 of 3 study arms involving several online sessions. We created 2 indirect measures of breadth and depth to measure different dimensions and dynamics of program engagement based on factor analysis of paradata measures of Web pages visited and time spent online with the intervention materials. Multiple regression was used to assess influence of engagement on retention and change in dietary intake. RESULTS: Baseline surveys were completed by 2513 enrolled participants. Of these, 86.3% (n = 2168) completed the follow-up surveys at 3 months, 79.6% (n = 2027) at 6 months, and 79.4% (n = 1995) at 12 months. The 2 tailored intervention arms exhibited significantly more engagement than the untailored arm (P < .01). Breadth and depth measures of engagement were significantly associated with completion of follow-up surveys (odds ratios [OR] = 4.11 and 2.12, respectively, both P values < .001). The breadth measure of engagement was also significantly positively associated with a key study outcome, the mean increase in fruit and vegetable consumption (P < .001). CONCLUSIONS: By exploring participants' exposures to online interventions, paradata are valuable in explaining the effects of tailoring in increasing participant engagement in the intervention. Controlling for intervention arm, greater engagement is also associated with retention of participants and positive change in a key outcome of the intervention, dietary change. This paper demonstrates the utility of paradata capture and analysis for evaluating online health interventions. TRIAL REGISTRATION: NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5u8sSr0Ty).

Recruitment to a randomized web-based nutritional intervention trial: characteristics of participants compared to non-participants.

BACKGROUND: Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll. OBJECTIVE: The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ. METHODS: The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment. RESULTS: Of 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame. CONCLUSIONS: Relative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations. TRIAL REGISTRATION: Clinicaltrials.gov NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5jB50xSfU).

A comparison of smokers' and nonsmokers' fruit and vegetable intake and relevant psychosocial factors.

The authors examined the relation between smoking status and fruit and vegetable (FV) consumption among a population-based sample and examined differences in psychosocial factors that may influence diet and inform intervention efforts. The authors recruited adults (N = 2,540) from 5 US health plans to participate in a Web-based dietary intervention trial. At baseline, smokers ate fewer FV servings per day (p < .001) and were less likely to meet the 5 A Day goal (p < .001). Smokers reported lower self-efficacy, overall motivation, and intrinsic motivation for meeting daily FV recommendations. Fewer smokers expected that eating 5 FV servings a day would reduce their risk for diabetes (p = .02) or obesity (p = .008). Smokers are an important target group for dietary intervention. Intervention efforts should attempt to increase smokers' motivation and confidence in their abilities to change their eating patterns and educate them about the health benefits of eating FV.

Use of antidepressant medications during pregnancy: a multisite study.

OBJECTIVE: This study was undertaken to provide information on the prevalence of use of antidepressant drugs among pregnant women in the United States. STUDY DESIGN: A retrospective study was conducted using the automated databases of 7 health plans. Women who delivered an infant in a hospital were identified. Antidepressant drug use was evaluated assuming a gestational duration of 270 days. RESULTS: Among the 118,935 deliveries occurring from 2001-2005, 6.6% of women were dispensed an antidepressant during pregnancy. Antidepressant drug use increased from 2.0% in 1996 to 7.6% of deliveries in 2004 and 2005. Selective serotonin reuptake inhibitor use increased from 1.5% in 1996 to 6.4% in 2004 and 6.2% in 2005. CONCLUSION: Our finding that nearly 8% of pregnant women were prescribed antidepressants drugs during the years 2004 and 2005 highlights the importance of understanding the effects of these medications on the developing fetus and on the pregnant woman.

Optimizing practice through research: a new perspective to solve an old problem.

Policy makers, researchers, clinicians, and the public are frustrated that research in the health sciences has not resulted in a greater improvement in patient outcomes. Our experience as clinicians and researchers suggests that this frustration could be reduced if health sciences research were directed by 5 broad principles: (1) the needs of patients and populations determine the research agenda; (2) the research agenda addresses contextual and implementation issues, including the development of delivery and accountability systems; (3) the research agenda determines the research methods rather than methods determines the research agenda; (4) researchers and clinicians collaborate to define the research agenda, allocate resources, and implement findings; and (5) the level of funding for implementation research is commensurate with and proportional to the magnitude of the task. To keep the research agenda focused on the task of improving health and to acknowledge that the effort must be seen as more comprehensive than translating or transferring research into practice (TRIP), we suggest that the task be reframed, using the term optimizing practice through research.

Outpatient use of cardiovascular drugs during pregnancy.

PURPOSE: To provide information on the prevalence of use of cardiovascular drugs, some of which may have fetotoxic or teratogenic effects, in the outpatient setting among pregnant women in the United States. METHODS: A retrospective study was conducted using the automated databases of seven health plans participating in the HMO Research Network Center for Education and Research on Therapeutics (CERT). Women who delivered an infant from 1 January 2001 to 31 December 2005 were identified. Cardiovascular drug use was evaluated assuming a gestational duration of 270 days. RESULTS: During the period 2001 through 2005, 118,935 deliveries were identified that met the criteria for study; 3.1% of women (N = 3672) were dispensed an antihypertensive medication and 0.12% of women (N = 146) were dispensed an antihyperlipidemic medication at any time during pregnancy. The most common antihypertensive drugs dispensed during pregnancy were nifedipine (1219 deliveries; 1.0%), methyldopa (961 deliveries; 0.8%), atenolol (593 deliveries; 0.5%), and labetalol (576 deliveries; 0.5%). Overall, 134 women (0.11%) received an angiotensin converting enzyme (ACE) inhibitor and 7 women (0.006%) received an angiotensin II receptor blocker (ARB) during pregnancy. Statins were the most commonly dispensed antihyperlipidemic drugs (71 deliveries; 0.06%). CONCLUSIONS: The prevalence of use of cardiovascular drugs that are suspected to be fetotoxic or teratogenic (ACE inhibitors, ARBs, and statins) was low in this cohort of pregnant women. Differing patterns of use across health plans suggests that further research is needed to evaluate the potential differential effects of cardiovascular drugs to assist prescribers and patients in making informed treatment decisions.

Positive, negative, and disparate--women's differing long-term psychosocial experiences of bilateral or contralateral prophylactic mastectomy.

Because of recent studies showing strong prevention benefit and acceptable psychosocial outcomes, more women may be considering prophylactic mastectomy. A growing literature shows some positive psychosocial outcomes for women with bilateral prophylactic mastectomy, but less is known about women with contralateral prophylactic mastectomy. Several surveys have shown that a large majority of women with prophylactic mastectomy report satisfaction with their decisions to have the procedure when asked in a quantitative, closed-ended format. We sought to explore the nuances of women's satisfaction with the procedure using a qualitative, open-ended format. We included open-ended questions as part of a mailed survey on psychosocial outcomes of prophylactic mastectomy. The research team coded and analyzed these responses using qualitative methods. We used simple descriptive statistics to compare the demographics of the entire survey sample to those women who answered the open-ended questions; the responses to the open- and closed-ended satisfaction questions, and the responses of women with bilateral and contralateral prophylactic mastectomy. Seventy-one percent of women with prophylactic mastectomy responded to the survey and 48% provided open-ended responses about psychosocial outcomes. Women's open-ended responses regarding psychosocial outcomes could be coded into one of three general categories--positive, negative, and disparate. In the subgroup of women with both open- and closed-ended responses, over 70% of women providing negative and disparate comments to the open-ended question simultaneously indicated satisfaction on a closed-ended question. Negative and disparate open-ended responses were twice as common among women with bilateral prophylactic mastectomy (52%) than women with contralateral prophylactic mastectomy (26%). These findings suggest that even among women who report general satisfaction with their decision to have prophylactic mastectomy via closed-ended survey questions, lingering negative psychosocial outcomes can remain, particularly among women with bilateral prophylactic mastectomy. This dichotomy could be an important factor to discuss in counseling women considering the procedure.

Provider management of menopause after the findings of the Women's Health Initiative.

OBJECTIVE: A survey was conducted to determine current provider behaviors and concerns related to menopause management. DESIGN: All gynecology, internal medicine, and family medicine providers (both physicians and nurse practitioners) within a large Midwestern integrated health system were surveyed about current approaches to menopause management, frequency and reasons for hormone therapy (HT) use, approaches to HT discontinuation, treatments for symptom control, bone mineral density testing, and concerns related to menopause management. Descriptive statistics and chi-square tests were performed to examine frequencies and differences based on gender, specialty, and years in practice. RESULTS: Overall the response rate was 58% with providers from owned clinics, with female providers being the most likely to respond (P < 0.001). Changes in menopause management included using lower dose hormones (74%), encouraging use for shorter time periods (73%), and using different modes of delivery (21%). Most providers (89%) initiate HT use in symptomatic patients, and only 12% initiate use to prevent symptoms. Patients were most likely to discuss HT with gynecologists (78% gynecologists vs 64% family medicine providers and 48% internal medicine providers, P = 0.015). Nearly two thirds of providers (64%) claimed to order bone mineral density testing frequently. Providers' concerns related to information on symptom management, alternative and over-the-counter medications, the risk/benefits of medications, patients' sexual concerns, and maintaining bone health. CONCLUSIONS: We found that providers were responsive to current literature, shifting the agents and dosages they prescribe. Still they are faced with women reporting symptoms that interfere with their ability to function optimally and must continue to help women maintain healthy bones.

Impact of chemotherapy in women with metastatic breast cancer diagnosed 1990-2003.

PURPOSE: In order to determine whether new treatments for advanced breast cancer resulted in improved survival, we analyzed treatment and survival trends in 232 women with metastatic breast cancer treated in the Minneapolis/St. Paul metropolitan area between 1990 and 2003. PATIENTS AND METHODS: Subjects were identified from area hospital tumor registries and the Minnesota Department of Health. Data on demographics, estrogen receptor status, location of metastases, and treatment were obtained from hospital tumor registries and medical records. RESULTS: A total of 95 patients were diagnosed between 1990 and 1995, and 137 were diagnosed between 1996 and 2003. Overall, there was no difference in survival for women treated between 1990 and 1995 and those treated from 1996 to 2003 (13 months vs. 19 months; P = .38). Chemotherapy recipients in the latter cohort had significantly longer survival than chemotherapy recipients in the earlier cohort (13 months vs. 29 months; P = .03). There were no differences found in survival between cohorts for women receiving hormonal therapy only (18 months vs. 16 months; P = .81). CONCLUSION: We conclude that newer chemotherapeutic agents have had an impact on survival in women with metastatic breast cancer. Newer hormonal agents did not have the same impact on survival in our study.

Specificity of clinical breast examination in community practice.

BACKGROUND: Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (approximately 94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity. OBJECTIVE: To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity. DESIGN: Retrospective cohort study. SUBJECTS: Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484). MEASUREMENTS: Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered "average-risk" if they had neither a family history of breast cancer nor a prior breast biopsy and "increased-risk" otherwise. RESULTS: Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8-99.7%] and 97.1% (95% CI: 95.7-98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7-76.5%) and 57.1% (95% CI: 51.1-63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10-0.46). CONCLUSIONS: Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.

Complications at the end of life in ovarian cancer.

Women dying of ovarian cancer vary considerably in their complications and in the types of health care they receive. The objective of this study was to describe the complications of ovarian cancer, other than pain, and their treatment at the end of life. This study used a cohort of 421 enrollees in three nonprofit managed-care organizations who died with ovarian cancer during 1995-2000. Data were collected from abstraction of paper and electronic medical records. Proportions of women experiencing complications and undergoing treatments were calculated. Logistic regression was used to evaluate the association of patient characteristics with the probability of receiving an intervention for complications. The most common complications recorded in the medical record were fatigue or weakness (75%), nausea or vomiting (71%), constipation (49%), edema of the extremities (44%), and anemia (34%). The prevalence of major complications was as follows: ascites, 28%; bowel obstruction, 12%; pleural effusion, 10%; bladder obstruction, 3%; and disordered nutrition that required support with parenteral nutrition, 9%. Patients may not always have received interventions for major complications; for example, pleural effusion apparently was left untreated in almost half of the women with this problem. After adjustment, women who died at younger ages were more likely to receive an intervention, compared to older women (odds ratio for each decade of age, 0.71, 95% confidence interval=0.53, 0.94, P for trend=0.02). The study, which preceded the establishment of palliative care programs, suggests that care given to ovarian cancer patients at the end of life may be inadequate.

Pain management in the last six months of life among women who died of ovarian cancer.

Previous studies indicate that the symptoms of many dying cancer patients are undertreated and many suffer unnecessary pain. We obtained data retrospectively from three large health maintenance organizations, and examined the analgesic drug therapies received in the last six months of life by women who died of ovarian cancer between 1995 and 2000. Subjects were identified through cancer registries and administrative data. Outpatient medications used during the final six months of life were obtained from pharmacy databases. Pain information was obtained from medical charts. We categorized each medication based on the World Health Organization classification for pain management (mild, moderate, or intense). Of the 421 women, only 64 (15%) had no mention of pain in their charts. The use of medications typically prescribed for moderate to severe pain ("high intensity" drugs) increased as women approached death. At 5-6 months before death, 55% of women were either on no pain medication or medication generally used for mild pain; only 9% were using the highest intensity regimen. The percentage on the highest intensity regimen (drugs generally used for severe pain) increased to 22% at 3-4 months before death and 54% at 1-2 months. Older women (70 or older) were less likely to be prescribed the highest intensity medication than those under age 70 (44% vs. 70%, P<0.001). No differences were found in the use of the high intensity drugs by race, marital status, year of diagnosis, stage of disease, or comorbidity. Our finding that only 54% of women with pain were given high intensity medication near death indicates room for improvement in the care of ovarian cancer patients at the end of life.

Impact of IRB requirements on a multicenter survey of prophylactic mastectomy outcomes.

OBJECTIVE: This study assesses the variability in requirements among six institutional review boards (IRBs) and the resulting protocol variations for a multicenter mailed survey. STUDY DESIGN AND SETTING: We utilized a cross-sectional mailed survey to gather information on long-term psychosocial outcomes of prophylactic mastectomy among women at six health maintenance organizations, all of which are part of the Cancer Research Network. In the context of this collaborative study, we characterized the impact of the different sites' IRB review processes on the study protocol and participation. RESULTS: IRB review resulted in site differences in physician consent prior to participant contact, invitation letter content and signatories, and incentive type. The review process required two to eight modifications beyond the initial application and resulted in unanticipated delays and costs. CONCLUSION: Site-to-site variability in IRB requirements may adversely impact scientific rigor and delay implementation of collaborative studies, especially when not considered in project planning. IRB review is an essential aspect of research but one that can present substantial challenges for multicenter studies.

Complications following bilateral prophylactic mastectomy.

BACKGROUND: Bilateral prophylactic mastectomy significantly decreases breast cancer risk, but complications of the procedure have only been described in single-site studies. We describe the frequency and type of complications in women who underwent bilateral prophylactic mastectomy in a multisite community-based cohort. METHODS: Women aged 18-80 years undergoing bilateral prophylactic mastectomy without a personal history of breast cancer at one of six health plans were eligible. We identified women from automated data sources, then reviewed hospital data, ambulatory notes, and other chart elements to confirm eligibility and obtain all charted information about complications and surgeries performed after prophylactic mastectomy, including reconstructive procedures. Reconstructions were characterized by type (implant vs. tissue graft). Complications were noted for a 1-year period after any surgical procedure. RESULTS: We identified 269 women with prophylactic mastectomy who were followed for a mean of 7.4 years. Their mean age was 44.9 years. Nearly 80% undertook reconstruction, most with prosthetic implants. One or more complications occurred in 64%. The most common complications were pain (35% of women), infection (17%), and seroma (17%). Women with no reconstruction had fewer complications (mean of .93) than women who had implant (2.0) or tissue graft (2.4) reconstruction procedures (differences from no reconstruction: 1.07 [95% confidence interval = 0.36 to 1.77] and 1.50 [95% confidence interval = 0.44 to 2.56] respectively). Delay of reconstruction after mastectomy was associated with a borderline-significant higher risk of complications (80.6%) compared to simultaneous reconstruction (64.0%, P = .055). CONCLUSION: We found that almost two-thirds of women undergoing bilateral prophylactic mastectomy had at least one complication following surgery. Further work should be done to minimize and to understand the effect of complications of bilateral prophylactic mastectomy.

Screening clinical breast examination: how often does it miss lethal breast cancer?

BACKGROUND: Although most American women regularly receive screening clinical breast examination (CBE), little is known about CBE accuracy in community practice. We sought to estimate the rate of cancer detection (sensitivity) of screening CBE performed by community-based clinicians on women who ultimately died of breast cancer, as well as to identify factors associated with accurate detection. SUBJECTS AND METHODS: We evaluated CBE accuracy among asymptomatic female health plan enrollees in five states (WA, OR, CA, MA, and MN) who received a CBE within 1 year of breast cancer diagnosis and who died of breast cancer within 15 years of diagnosis (N = 485). Sensitivity was estimated as the proportion whose exam was abnormal. Bivariate and logistic regression analyses identified patient characteristics associated with cancer detection. RESULTS: An abnormality was noted on screening CBE in one of five women who ultimately succumbed to breast cancer (sensitivity = 21.6%; 95% confidence interval [CI] = 18.1% to 25.6%). The odds of a true-positive screening CBE (sensitivity) were decreased among women using estrogen (odds ratio [OR] = 0.23; 95% CI = 0.07 to 0.80), receiving a Pap smear during the same visit as CBE (OR = 0.45; 95% CI = 0.27 to 0.72), and with increasing chronic disease comorbidity (P(trend) = .08). CONCLUSION: Screening CBE as performed in the community may be insufficiently sensitive to detect most lethal breast cancers. Low sensitivity of screening CBE in community practice may be partly attributable to its performance alongside time-consuming clinical tasks such as Pap smear screening or chronic illness care.