Tamoxifen's protection against breast cancer recurrence is not reduced by concurrent use of the SSRI citalopram.

Tamoxifen remains an important adjuvant therapy to reduce the rate of breast cancer recurrence among patients with oestrogen-receptor-positive tumours. Cytochrome P-450 2D6 metabolizes tamoxifen to metabolites that more readily bind the oestrogen receptor. This enzyme also metabolizes selective serotonin reuptake inhibitors (SSRI), so these widely used drugs - when taken concurrently - may reduce tamoxifen's prevention of breast cancer recurrence. We studied citalopram use in 184 cases of breast cancer recurrence and 184 matched controls without recurrence after equivalent follow-up. Cases and controls were nested in a population of female residents of Northern Denmark with stages I-III oestrogen-receptor-positive breast cancer 1985-2001 and who took tamoxifen for 1, 2, or most often for 5 years. We ascertained prescription histories by linking participants' central personal registry numbers to prescription databases from the National Health Service. Seventeen cases (9%) and 21 controls (11%) received at least one prescription for the SSRI citalopram while taking tamoxifen (adjusted conditional odds ratio=0.85, 95% confidence interval=0.42, 1.7). We also observed no reduction of tamoxifen effectiveness among regular citalopram users (>or=30% overlap with tamoxifen use). These results suggest that concurrent use of citalopram does not reduce tamoxifen's prevention of breast cancer recurrence.

Nutritional risk in an urban homebound older population. The nutrition and healthy aging project.

PURPOSE: To establish the prevalence of nutritional problems and their related socio-demographic and health-related risk factors in the homebound elderly population. METHODS: Subjects included 239 men and women, ages 65 to 105 years. Trained, two-person field teams conducted comprehensive in-home assessments. Medical record reviews assessed co-morbidity and medication use. RESULTS: The majority of these urban study subjects are of very advanced age (mean age 81 years), female (72%), non-white (73%), living alone (51%), of low income (76%), and somewhat socially isolated (26% had no weekly social contact). More older women than men were widowed (60 vs. 33%, respectively) and poor (80 vs. 67%). The disease burden and functional dependency were both high in men and women; 77% had three or more chronic medical conditions; 76% were functionally dependent in one or more ADL's and 95% in one or more IADL's. Poor dietary quality was universal in these older men and women; half or more consumed diets that deviated from recommended standards for at least 13 of the 24 nutritional guidelines studied. Five percent of subjects were underweight (Body Mass Index (BMI) <18.5); 22% were overweight (BMI 25.0-29.9); and 33% were obese (BMI >30.0). Fasting albumin, hemoglobin, and absolute lymphocyte concentrations were borderline to very low in 18-32%. Dyslipidemia was more common in women; however, men and women had similar Total:HDL cholesterol ratios. CONCLUSIONS: Nutritional status is poor in homebound persons of very advanced age with substantial co-morbidity and functional dependency. The complexities of nutritional risk necessitate multi-disciplinary and individualized nutritional intervention strategies.

The treating physician as active gatekeeper in the recruitment of research subjects.

BACKGROUND: Institutional Review Boards vary in regard to the conditions imposed on investigators concerning contacting potential subjects to participate in health-services research studies. OBJECTIVE: The impact of more active involvement of the treating physician was examined in the approval process for recruiting study subjects. DESIGN: In recruiting subjects for a Massachusetts-based, multihospital (n = 17), health-services research study of treatment patterns for early stage breast cancer that required patient interviews, four hospitals stipulated that the treating surgeon provide written permission to the investigators to allow any contact with a potential study subject for the purpose of recruitment (active physician involvement group); the remaining 13 hospitals stipulated that the treating surgeon need only respond to the investigators if contact with a potential subject was forbidden (passive physician involvement group). SUBJECTS: Of the 1401 potential subjects treated for early stage breast cancer, 697 were in the active physician involvement group and 704 were in the passive physician involvement group. MEASURES: The percentages of patients for whom contact was allowed for recruitment purposes and who enrolled in the study were determined for the active physician involvement group and the passive physician involvement group, respectively. Logistic regression models were used to assess the independent effect of physician involvement on study enrollment. RESULTS: Of the 697 patients in the active physician involvement group, contact was approved by the treating surgeon for 72% (n = 505), compared with 91% (n = 638) of the passive physician involvement group (P <0.001). After adjustment for a variety of patient, physician, and hospital-level variables, patients in the passive physician involvement group were found to be significantly more likely to be enrolled in the study (adjusted OR 2.61; 95% CI, 1.53-4.45). However, among those patients approved for investigator contact, there were no significant differences between patients who were enrolled and patients who were not enrolled in the study with regard to physician involvement in the recruitment process (adjusted OR 1.13; 95% CI, 0.70-1.81). CONCLUSION: Our findings demonstrate that more stringent IRB requirements on health services researchers to verify permission from the treating physician to access patients for recruitment purposes adversely impact on the enrollment of patients even in noninterventional research studies. Current procedures for involving the treating physician as a gatekeeper in the recruitment of research subjects may limit access to patient participation in research studies from the perspectives of both researchers and potential subjects.

Sexuality after treatment for early prostate cancer: exploring the meanings of "erectile dysfunction".

OBJECTIVE: To explore perceptions of the impact of erectile dysfunction on men who had undergone definitive treatment for early nonmetastatic prostate cancer. DESIGN: Seven focus groups of men with early prostate cancer. The groups were semistructured to explore men's experiences and quality-of-life concerns associated with prostate cancer and its treatment. SETTING: A staff model health maintenance organization, and a Veterans Affairs medical center. PATIENTS: Forty-eight men who had been treated for early prostate cancer 12 to 24 months previously. RESULTS: Men confirmed the substantial effect of sexual dysfunction on the quality of their lives. Four domains of quality of life related to men's sexuality were identified: 1) the qualities of sexual intimacy; 2) everyday interactions with women; 3) sexual imagining and fantasy life; and 4) men's perceptions of their masculinity. Erectile problems were found to affect men in both their intimate and nonintimate lives, including how they saw themselves as sexual beings. CONCLUSIONS: Erectile dysfunction, the most common side effect of treatment for early prostate cancer, has far-reaching effects upon men's lives. Assessment of quality of life related to sexual dysfunction should address these broad impacts of erectile function on men's lives. Physicians should consider these effects when advising men regarding treatment options. Physicians caring for patients who have undergone treatment should address these psychosocial issues when counseling men with erectile dysfunction.

Medical surveillance after breast cancer diagnosis.

OBJECTIVES: To characterize the tests ordered for surveillance of breast cancer recurrence in the 4 years after breast cancer diagnosis by surgeons, medical oncologists, and radiation oncologists. RESEARCH DESIGN: 303 stage I or II breast cancer patients age 55-years or older and diagnosed at 1 of 5 Boston hospitals. Patient interviews and medical record abstracts provided the data to characterize patient demographics, the breast cancer stage and its primary therapy, and the surveillance procedures ordered. RESULTS: 279 of the 303 women had some surveillance testing. Among those who received some surveillance, a mean of 22.0 tests were ordered, most by their medical oncologists (mean = 14.4), followed by their surgeons (mean = 9.7) and their radiation oncologists (mean = 5.7). The most common test was a mammogram (mean = 3.9). Women ages 75 to 90 years old were at higher risk for failure to complete four consecutive years of surveillance and for receipt of less than guideline surveillance. Younger women, women treated at a breast cancer center with a unified patient chart, and women who worked full or part time were at lower risk for failure to complete 4 years of surveillance. CONCLUSION: Most women in this cohort received some surveillance after completing primary therapy for breast cancer. Although no woman's surveillance corresponded exactly to existing guidelines, the oldest women were least likely to receive guideline surveillance. Surveillance after breast cancer therefore joins the list of aspects of breast cancer care-breast cancer screening, diagnosis, prognostic evaluation, and primary therapy-for which older women receive less than definitive care.

A comparison of the National Death Index and Social Security Administration databases to ascertain vital status.

We compared vital status follow-up by the National Death Index and the Social Security Administration for a cohort of breast cancer patients. Only the National Death Index allowed follow-up for subjects with an unknown Social Security number. All of the deaths identified by the Social Security Administration were reported by the National Death Index. No subject reported to be alive by the Social Security Administration matched a National Death Index record. Subjects with inaccurate identifying information were more effectively followed up by the National Death Index. The National Death Index more accurately reported dates of death.

Adjuvant tamoxifen: predictors of use, side effects, and discontinuation in older women.

PURPOSE: To identify predictors of adjuvant tamoxifen use, side effects, and discontinuation in older women. PATIENTS AND METHODS: We followed a cohort of 303 women > or = 55 years of age diagnosed with stage I or stage II breast cancer for nearly 3 years. Data were collected from women's surgical records and from computer-assisted telephone interviews at 5, 21, and 33 months after primary tumor therapy. RESULTS: Two hundred ninety-two (96%) of 303 patients in the study provided information about tamoxifen use. Tamoxifen use was reported by 189 patients (65%); 26 (15%) discontinued use during the follow-up period. Patients who were 65 to 74 years of age (relative to those 55 to 64 years of age), had stage II disease, were estrogen receptor-positive, saw a greater number of breast cancer physicians, and had better perceptions of their abilities to discuss treatment options with physicians had greater odds of tamoxifen use. Those who had better physical function, had received standard primary tumor therapy, and had obtained helpful breast cancer information from books or magazines had lesser odds of tamoxifen use. Patients > or = 75 years of age (relative to those 55 to 64 years of age) and patients with better emotional health had significantly lesser odds of reporting side effects. Patients who were estrogen receptor-positive were less likely to stop taking tamoxifen; patients who experienced side effects were more likely to stop taking tamoxifen. CONCLUSION: Deviations from a prescribed course of adjuvant tamoxifen occur relatively frequently. The clinical consequences of this deviation need to be identified.

Screening mammography and breast cancer treatment patterns in older women.

OBJECTIVE: To examine the impact of mammography screening on treatment options received by a cohort of older breast cancer patients. SETTING AND POPULATION: We studied 718 newly diagnosed breast cancer patients, 67 years and over, diagnosed with TNM Stage I and II disease between 1995 and 1997 at 29 hospitals in five regions. METHODS: Data were collected from patients, surgeons, and medical records. A breast cancer diagnosis was considered to have been by screening mammography if so reported by both patient and medical records. Bivariate and logistic regression were used to identify predictors of a women having her cancer detected by screening mammography and the relationships between mode of detection, stage of disease at diagnosis, and local treatment. RESULTS: Women with high school or greater education were 1.75 times (95%, CI 1.11-2.75) more likely to have their cancers diagnosed by screening mammography than women who had not completed high school, controlling for other factors. Screening found earlier stage disease: 96% of women with mammographically diagnosed cancer had T1 lesions, compared to 81% of women diagnosed by other means (p = 0.001). Women with mammography detected lesions were more likely to have ductal cancer, and to be referred to radiation oncologists more than women diagnosed by other means. Controlling for stage and histology, screening remained associated with a higher likelihood of receiving breast conserving surgery (BCS) with radiation (RT) (OR 1.56, 95%, CI 1.10-2.22) than other local therapies. CONCLUSIONS: Beyond the impact on stage, ductal cancers were more likely to be diagnosed by screening. Mammographically detected lesions were associated with referrals to radiation oncologists and higher rates of BCS and RT. Research is needed to explain the residual independent effects of mammography screening on breast cancer treatment.

Constructs of burden of illness in older patients with breast cancer: a comparison of measurement methods.

OBJECTIVE: The burden of illness can influence treatment decisions, but there are limited data comparing the performance of different illness burden measures. We assessed the correlations between five previously validated measures of illness burden and global health and physical function and evaluated how each measure correlates with breast cancer treatment patterns in older women. DATA SOURCE: A cohort of 718 women > 67 years with early-stage breast cancer formed the study group. STUDY DESIGN/DATA COLLECTION METHODS: The study made a cross-sectional comparison of illness burden measures (Charlson index, Index of Co-existent Diseases, cardiopulmonary burden of illness, patient-specific life expectancy, and disease counts) and physical function and self-rated global health status. Data were collected from records and patient interviews. PRINCIPAL FINDINGS: All of the measures were significantly correlated with each other and with physical function and self-rated health (p < .001). After controlling for age and stage, life expectancy had the largest effect on surgical treatment, followed by self-rated physical function and health; life expectancy was also independent of physical function. For instance, women with higher life expectancy and better self-rated physical function and health were more likely to receive breast conservation and radiation than sicker women. Women with higher physical functioning were more likely to receive adjuvant chemotherapy than women with lower functioning. CONCLUSIONS: Several measures of illness burden were associated with breast cancer therapy, but each measure accounted for only a small amount of variance in treatment patterns. Future work is needed to develop and validate measures of burden of illness that are feasible, comprehensive, and relevant for diverse clinical and health services objectives.

The effect of less than definitive care on breast carcinoma recurrence and mortality.

BACKGROUND: Risk factors for breast carcinoma offer few opportunities for prevention; thus, the reduction of morbidity and mortality among breast carcinoma patients must remain a priority. The objective of this study was to measure the effects of less than definitive care for patients with breast carcinoma on disease recurrence and mortality. METHODS: The prognostic evaluation and treatment received by an inception cohort of 494 women was characterized. Three hundred ninety women ages 45-90 years with local or regional breast carcinoma who were diagnosed between 1984 and 1986 and were treated at one of eight Rhode Island hospitals comprised the final cohort. Disease recurrence and mortality were ascertained through December 31, 1996. Candidate determinants of outcomes were a less than definitive prognostic evaluation and less than definitive primary therapy-adjusted for confounding by patient age, extent of disease, and comorbid diseases. RESULTS: During the first 5 years of follow-up, patients who received a less than definitive prognostic evaluation had an adjusted relative hazard of recurrence of 1.7 (95% confidence interval, 1.0-2.7) and an adjusted relative hazard for breast carcinoma mortality of 2.2 (95% confidence interval, 1.2-3.9). Patients who received less than definitive therapy had an adjusted relative hazard of recurrence of 1.6 (95% confidence interval, 1.0-2.5), and an adjusted relative hazard of breast carcinoma mortality of 1.7 (95% confidence interval, 1.0-2.8). CONCLUSIONS: Breast carcinoma patients who receive less than definitive care are at excess risk for disease recurrence and mortality. Women with early stage breast carcinoma should be treated in accordance with existing guidelines.

A sensitivity analysis to separate bias due to confounding from bias due to predicting misclassification by a variable that does both.

Variables that predict misclassification of exposure, outcome, or a confounder cannot be controlled by techniques that adjust for predictors of risk. They must be controlled by external adjustments. We confronted an analysis in which a variable predicted misclassification of the exposure and of a confounder. The same variable confounded the exposure-outcome relation. The analysis focused on the relation between less-than-definitive therapy and breast cancer mortality in the 5 years after diagnosis. Receipt of less-than-definitive prognostic evaluation predicted misclassification of definitive therapy (the exposure) and stage (a confounder). Prognostic evaluation also confounded the therapy-breast cancer mortality relation. We used a sensitivity analysis to separate the misclassification biases from the confounding bias. The relative hazard associated with less-than-definitive therapy in the original multivariable model equaled 1.75 (95% confidence interval = 1.02-3.00). The median estimate in 2,500 repetitions of the sensitivity analysis was a relative hazard of 1.64, and 90% of the estimates fell between 1.47 and 1.83. The sensitivity analysis suggests that less-than-definitive therapy confers an excess relative hazard of breast cancer mortality in the 5 years after diagnosis. The original analysis, which adjusted for confounding by prognostic evaluation but not its misclassification biases, overestimated the relative hazard.

Oral health problems and significant weight loss among community-dwelling older adults.

BACKGROUND: Studies of hospitalized and institutionalized older adults suggest a relationship between poor oral health and subsequent weight loss. Given the association between weight loss and subsequent mortality and morbidity, we evaluated how oral health problems contributed to significant weight loss over a 1-year period among a representative sample of community-dwelling older adults. METHODS: The study population consisted of 563 adults aged 70 years and older living at home in rural and urban areas in six New England states. Baseline data included information regarding health status, functional status, physical activity, disease diagnoses, lifestyle behaviors, and cognitive and affective status. Dentists performed oral health assessments. One year later, participants were called and asked questions regarding their health and dietary practices and their current weight. RESULTS: Over the 1-year period of follow-up, approximately one third of the sample had lost 4% or more of their previous total body weight; 6% of men and 11% of women lost 10% or more of their previous body weight. Of the subjects, 37% were edentulous; most of these individuals wore full dentures. With gender, income, advanced age, and baseline weight controlled for, edentulousness remained an independent risk factor for significant weight loss (odds ratio 1.63 for 4% weight loss and 2.03 for 10% weight loss). Individuals with increasing numbers of posterior teeth and functional units were at slightly lower risk for weight loss; however, these associations did not reach statistical significance. CONCLUSIONS: Dentate status is an important risk factor for clinically significant weight loss among community-dwelling older adults.

What can we do to improve physical function in older persons with type 2 diabetes?

BACKGROUND: Older persons with type 2 diabetes are at higher risk for functional impairment than are their age-matched counterparts without-diabetes. We therefore sought to identify factors associated with impaired physical function in older persons with type 2 diabetes by using a cross-sectional study design. METHODS: We studied 1238 persons with type 2 diabetes who were 55 years of age or older and enrolled in the Type II Diabetes Patient Outcomes Research Team (PORT) project. Subjects were primary care patients at a large staff model health maintenance organization who had completed a mailed survey that collected information about demographics (age, race, marital status, income, education, gender, and body mass index [BMI]), health behaviors (exercise, smoking, and alcohol), care and control of diabetes (therapy, self-reported glucose control, home glucose monitoring, and disease duration), mood (Center for Epidemiologic Studies--Depression Scale [CES-D]), comorbidity, and the Short-Form-36 health survey (SF-36). We evaluated the bivariate relationships between the PFI- 10, a 10-item measure of physical function from the SF-36, and candidate independent variables from the domains described previously. Variables that were significant at an a level of .10 were entered into a multiple linear regression model. RESULTS: There were eight independent predictors of impaired physical function (all p < .05, R2 = .40). Factors associated with impaired function in order of their relative importance were as follows: a higher comorbidity score, older age, obesity, lack of regular exercise, CES-D score higher than 20, taking insulin, lower formal education, and abstinence from alcohol. CONCLUSIONS: Increased comorbidity and older age are associated with poorer function, as is the severity of diabetes and less formal education. Exercise, lower BMI, and better mood are associated with better function. Therefore, promoting regular exercise and weight loss, in addition to treating depression, are likely to preserve or even improve the functional status of older persons with type 2 diabetes. Moderate alcohol use may be beneficial as well. The extent to which these relationships persist in prospective studies or clinical trials remains to be evaluated.

Patient characteristics and treatments associated with a decline in upper-body function following breast cancer therapy.

Breast cancer therapy is often followed by a decline in upper-body function. Women (303) diagnosed with stage I or II breast cancer were interviewed 5 and 21 months after surgery and their medical records were reviewed. Women with cardiopulmonary comorbidity had an odds ratio for decline at the 5-month interview of 2.8 (95% CI 1.3-5. 7), relative to women without. Women who received mastectomy (OR = 2. 5; 95% CI 0.9-6.7) or breast-conserving surgery with radiation therapy (OR = 2.9; 95% CI 1.0-8.9) were at higher risk for decline at the 5-month interview than women who received only breast-conserving surgery. Women who had axillary dissection were more likely to report numbness or pain in the axilla (OR = 6.4; 95% CI 1.2-33) at the 21-month interview than women who did not. Clinicians should consider the functional consequences of treatment when discussing treatment options and postoperative care with women who have early stage breast cancer.

Caregiving issues in the geriatric medical encounter.

Families provide much-needed care for dependent older persons, which can be both burdensome and stressful. In addition to providing personal care, families often are essential for optimal chronic disease management. Thus, two critical functions of the medical encounter are to provide empathic support to family caregivers and to provide education about chronic diseases and their management. Concomitantly, a conscious effort must be made to not compromise the doctor-older patient relationship, insofar as possible. Managing the doctor-patient-family caregiver relationship is challenging, especially in the settings of cognitive impairment and end-of-life care. In these circumstances in particular, both older patients and their families need the care of their physicians.

The care of older women with early-stage breast cancer: what is the role of surgeon gender?

BACKGROUND: Over the past decade and a half, a substantial literature has documented age-dependent variations in breast cancer care. Accumulating evidence suggests that these variations impact the health outcomes of older women with breast cancer. Surgeon gender may be an important source of age-dependent variations in care. OBJECTIVE: To examine the relationship between surgeon gender and primary tumor therapy and systemic adjuvant therapy among 303 older women with early-stage breast cancer cared for by 20 surgeons in Boston, Massachusetts. METHODS: The research design was a cross-sectional observational study. The subjects were women at least 55 years of age with newly diagnosed Stage I or II breast cancer. The main outcome measure was definitive primary tumor therapy and systemic adjuvant therapy. RESULTS: After adjustment for patient and tumor characteristics, patients of female surgeons were more likely to receive definitive treatment, with the strongest effect being observed for the receipt of both definitive primary tumor therapy and systemic adjuvant therapy (odds ratio 4.5; 95% confidence interval 2.7, 7.7). CONCLUSIONS: Women with early-stage breast cancer cared for by female surgeons are more likely to receive standard therapies. Surgeons provide the initial care, both diagnostic and therapeutic, for all women with breast cancer. Their role in breast cancer care is pivotal and has a substantial impact on the nature of breast cancer care received.

Risk factors for a decline in upper body function following treatment for early stage breast cancer.

PURPOSE: To identify risk factors for a decline in upper body function following treatment for early stage breast cancer. METHODS: We conducted a cross-sectional observational study of 213 women > 55 years of age newly diagnosed with early stage breast cancer interviewed three to five months following their definitive surgery. Patients were classified as having impaired upper body function related to their breast cancer treatment if: 1) they reported having no difficulty in performing any of three tasks requiring upper body function (pushing or pulling large objects; lifting objects weighing more than 10 pounds; and reaching or extending arms above shoulder level) prior to treatment, but reported that any of these tasks were somewhat or very difficult in the four weeks prior to interview, or 2) they reported that performing any of the three tasks requiring upper body function was somewhat difficult prior to treatment, but reported that any of these tasks were very difficult in the four weeks prior to interview. RESULTS: In multiple logistic regression models, both the extent and type of primary tumor therapy and cardiopulmonary comorbidity were significantly associated with a decline in upper body function following breast cancer treatment. CONCLUSION: Given the critical importance of upper body function in maintaining independent living, clinicians should consider the functional consequences of treatment when they discuss treatment options and post-operative care with older women who have early stage breast cancer.

Comparison of interview-based and medical-record based indices of comorbidity among breast cancer patients.

OBJECTIVES: To compare patient interview-based and medical-record based measures of comorbidity and their relation to primary tumor therapy, all cause mortality, self-reported upper body function, and overall physical function. METHODS: Three-hundred and three breast cancer patients (> or = 55 years) who were diagnosed in 1 of 5 Boston hospitals were enrolled. Patient interviews and medical record abstracts provided the information necessary to construct the Charlson index, Satariano index, and a new interview-based index of cardiopulmonary comorbidity. Those indices were used alone and in combination to predict the patient outcomes. RESULTS: The indices of comorbidity corresponded well with one another. No index of comorbidity predicted mortality or receipt of definitive primary therapy. The new interview-based index of cardiopulmonary comorbidity was a better predictor of upper body function and overall physical function than was the interview-based or medical record-based Charlson or Satariano indices of comorbidity. CONCLUSION: Older breast cancer patients are able to provide information about their diseases and related symptoms that correlates well with medical record-based measures of comorbidity and displays similar patterns of predictive power. A new self-reported measure of cardiopulmonary comorbidity performs better than the medical record-based measures for predicting patient related functional outcomes.