A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients with previously untreated mantle cell lymphoma; SWOG 0213.

BACKGROUND: Rituximab-hyper-CVAD alternating with rituximab-high-dose methotrexate and cytarabine is a commonly utilized regimen in the United States for mantle cell lymphoma (MCL) based on phase II single institutional data. To confirm the clinical efficacy of this regimen and determine its feasibility in a multicenter study that includes both academic and community-based practices, a phase II study of this regimen was conducted by SWOG. PATIENTS AND METHODS: Forty-nine patients with advanced stage, previously untreated MCL were eligible. The median age was 57.4 years (35-69.8 years). RESULTS: Nineteen patients (39%) did not complete the full scheduled course of treatment due to toxicity. There was one treatment-related death and two cases of secondary myelodysplastic syndrome (MDS). There were 10 episodes of grade 3 febrile neutropenia, 19 episodes of grade 3 and 1 episode of grade 4 infection. With a median follow-up of 4.8 years, the median progression-free survival was 4.8 years (5.5 years for those ≤ 65 years) and the median overall survival (OS) was 6.8 years. CONCLUSIONS: Although this regimen is toxic, it is active for patients ≤ 65 years of age and can be given both at academic centers and in experienced community centers.

Mammography use among women as a function of age and patient involvement in decision-making.

OBJECTIVE: To assess the extent to which self-reported patient involvement in decision-making for initiation of mammography differs with age. DESIGN: Data from the 1992 National Health Interview Survey (NHIS) Cancer Control Supplement were evaluated. Prevalences were weighted and variances were adjusted using SUDAAN software to account for the complex, multistage sampling probability design of the NHIS. Logistic regression was used to evaluate the relative likelihood of self-reported involvement in the decision to have a mammogram within the preceding year as a function of age and other covariates. PARTICIPANTS: Mammography use was assessed among 3,863 NHIS female respondents 40 years of age or older. The analysis of decision-making was restricted to the subgroup of 1,064 women who reported a screening mammogram within the preceding year and who provided information on the other relevant variables. MEASUREMENTS AND MAIN RESULTS: The probability of reported mammography use within the preceding year declines among older groups of interviewees. Among women with a mammogram in the preceding year, the weighted percentage of women reporting active involvement in the decision (patient decision or decided jointly with a physician) declines from 51% among women 40 to 45 years of age to 19% among those aged 75 years or older. The adjusted odds ratio comparing the likelihood of participating in the decision to have a mammogram for the oldest women, compared with the youngest, was 0.31 (95% confidence interval 0.15 to 0.61). CONCLUSIONS: Older women are substantially less likely than younger women to report active involvement in the mammography decision-making process. Increased use of screening mammography among older women will require greater promotion by physicians. Other interventions, such as directed educational efforts, may also be needed to increase mammography demand among older women.

Interrelationships of general internal medicine and preventive/community medicine.

Clinical preventive medicine, efforts by clinicians to prevent disease in individual patients, is an important component of preventive medicine as a whole. Yet clinicians, including internists, apparently do not provide many preventive services of established effectiveness. This paper describes one approach to improving the practice of clinical preventive medicine: increased cooperation between general internists--one of the nation's largest groups of primary care physicians--and specialists in preventive/community medicine. The paper summarizes a larger report prepared by two societies representing these disciplines: the Society for Research and Education in Primary Care Internal Medicine and the Association of Teachers of Preventive Medicine. It was found that the two disciplines have many common goals, and much to offer each other, but do not often collaborate. The report concludes with 14 recommendations for improving the practice of clinical preventive medicine, which suggest that such improvement can be achieved in part through strengthening working relationships between general internists and preventive/community medicine specialists.

Screening for prostate cancer. The challenge of promoting informed decision making in the absence of definitive evidence of effectiveness.

Evidence demonstrating the burden of prostate cancer upon men in the United States is incontrovertible; less compelling, however, is proof of benefit from early detection efforts. Nevertheless, the absence of definitive evidence does not lessen the interest of men in prostate testing or the obligation of physicians to help interested men make well-informed decisions, which integrate personal circumstance and preference with the best available data. This article provides the counseling physician with the information required to frame the current prostate testing debate and an approach to support informed decision making by men who can benefit from their assistance.

A time-motion study of the activities of attending physicians in an internal medicine and internal medicine-pediatrics resident continuity clinic.

PURPOSE: To describe the activities of attending physicians in a residency-based continuity clinic and to examine factors that affect their teaching of, supervision of, and interaction with residents. METHOD: Six full-time board-certified faculty members (three internal medicine, three internal medicine-pediatrics) in an urban residency program participated in a descriptive observational time-motion study. The attending faculty were directly observed by "shadow" technique for 30 half-day sessions from April 1994 through September 1994. Each activity was measured by a trained research assistant using a digital stopwatch. The observed activities were assigned to one of 16 subcategories. RESULTS: 6,389 minutes of activities were observed. Activities were distributed among four general categories: direct contact with residents (43.1%), clinic operations (33.7%), personal and/or professional activities (18.0%), and miscellaneous time (5.2%). Attending physicians spent the most time in direct contact with residents when the patient-to-attending ratio was 10-14:1. DISCUSSION: The activities of the clinic's attending physicians were quite varied. Less than half of their time in the clinic was spent in contact with residents. This contact time may be significantly increased by changes to clinic policies, such as optimizing the patient-to-faculty ratio and increasing administrative support for the clinic. These findings can be used as a reference point for studies of attending physicians' activities since the federally mandated rules changes regarding their responsibilities for supervising residents.

Fifteen years of a videotape review program for internal medicine and medicine-pediatrics residents.

The medical interview remains the most valuable component in patient evaluation. In addition to its diagnostic usefulness, it is the foundation upon which the doctor-patient relationship is built. It is essential, therefore, that health care providers be well trained in interviewing. Evidence suggests that having residents conduct videotaped interviews with patients and review the videotapes with faculty is an excellent way to teach interviewing skills. Videotape review has been part of the residency programs in primary care internal medicine and medicine-pediatrics at Wayne State University School of Medicine for 15 years. Throughout the history of the videotape program, the authors have endeavored to make the review process less stressful for residents by ensuring that the reviews are nonthreatening, nonjudgmental, and learner-centered. In this paper, the authors discuss (1) the structure and process of the videotape review program; (2) recurrent themes of the review sessions; (3) residents' perspectives on the process; and (4) potential barriers to a successful videotape review program and suggestions for how to avoid or overcome them.

Follow-up among women with an abnormal mammogram in an HMO: is it complete, timely, and efficient?

OBJECTIVE: To describe the extent to which women with seriously abnormal mammograms complete indicated follow-up, the timeliness of this follow-up, and variations in the pattern of use of diagnostic procedures. STUDY DESIGN: Retrospective chart review. PATIENTS AND METHODS: Ninety-two women enrolled in a single urban health maintenance organization (HMO) with an abnormal index mammogram (mass or suspicious calcifications) during 1995 or 1996 were identified by review of all HMO mammography reports. Data were abstracted from medical records concerning all clinical services received over the 11 months after the date of the abnormal mammogram. Procedure costs were estimated based on 1997 Medicare relative-value units. Logistic regression and a multivariate accelerated failure-time model were used to evaluate the association between predictor variables and the occurrence and timing of completion of follow-up. RESULTS: Follow-up was not completed by 31 (34%) of the 92 study women and was delayed beyond 60 days for another 32 (35%). In adjusted analysis, factors associated with completion within 60 days included age less than 50 years and inclusion of a specific follow-up recommendation in the mammogram report. Completion by the end of the study (a minimum of 11 months after the index mammogram) was associated only with the presence of a specific follow-up recommendation. The follow-up process (i.e., the diagnostic procedures used) was highly variable but almost always included surgical evaluation. The average cost among those completing follow-up was about $1900 (in 1997 dollars). CONCLUSIONS: Incomplete follow-up after a potentially seriously abnormal mammogram constitutes an important barrier to breast cancer control efforts in the study HMO, but its explanation remains incompletely understood. The follow-up process itself is highly variable, and improvement in its efficiency and timely completion will require a better understanding of its determinants.

Young teenagers' attitudes towards general practitioners and their provision of sexual health care.

BACKGROUND: Pregnancy rates in under-16-year old teenagers and sexual risk-taking are both increasing. Ensuring that teenagers access health care--particularly sexual health care--appropriately is problematic. AIM: To find out the opinions and attitudes of 13- to 15-year-old teenagers towards general practice-based sexual health care services. METHOD: A quantitative survey, using a questionnaire completed during school hours. RESULTS: One thousand and forty five children aged 13 to 15 years completed questionnaires. The majority (709 [68%]) were aware of the sexual health services offered by general practitioners (GPs), and 786 (75%) were positive about being given helpful advice at a consultation. However, 567 (54%) teenagers believed they had to be over 16 years old to access sexual health services and 604 (58%) were concerned about their confidentiality not being preserved by their GP. They were also concerned about GPs not having the time or skills to deal with their problems (314 [30%]). CONCLUSIONS: This study suggests that work is needed to improve teenagers' access to, and use of, primary care sexual health services. In particular, identifying strategies that improve teenagers' awareness of services and general practitioners' approaches towards teenagers are priorities.

Detroit's avoidable mortality project: breast cancer control for inner-city women.

Mammography remains substantially under-used in low-income minority populations despite its well-established efficacy as a means of breast cancer control. The Metropolitan Detroit Avoidable Mortality Project is a 2-year controlled clinical trial of coordinated interventions which seek to improve the use of early breast cancer detection services at five clinical sites providing primary health care services to inner-city women. Baseline assessment for two of the five participating clinic populations demonstrated that only one-quarter of women who visited these clinics were referred for mammography in 1988, and only half of those who were referred were able to complete the procedure. Patient characteristics including age, marital status, ethnicity, and insurance status were not associated with use of mammography during the baseline period. Each of the project's intervention components is a cue to action: a physician prompt for mammography referral within the medical record of procedure-due women, a reminder postcard for scheduled appointments, and a telephone call to encourage rescheduling of missed appointments. The interventions are initiated by a computerized information management system in the existing network of health care services. The patient's out-of-pocket mammography expense has been eliminated in three of the five sites. Although their efficacy as individual interventions has been well established, a controlled trial of computer prompts to physicians, reduced expense for patients, and patient appointment reminders as an integrated system in inner-city medical care settings has not been previously described. We have implemented the prompting, facilitated rescheduling procedures, and eliminated patient expense for mammography at three of five eventual clinical sites. This report provides an overview of the study's design, data management system, and methodology for evaluation.

Predictors of mammography use in the past year among elderly women.

Thirty-two personal characteristics were examined as potential predictors of mammography use in the past year in a geriatric clinic. Interviews assessed demographic, health status, health service utilization, health belief, and psychological and social variables (n = 242, mean age = 76 years). Four variables were independently associated with mammography use in logistic regression analysis: age, historical mammography use, perceived severity, and perceived barriers. The inverse relationship between age and mammography use in the past year was not modified by health status, functional status, and the other independently predictive variables. The authors conclude that geriatrics specialty care does not eliminate the age-associated decline in mammography use that has been previously described. The factors associated with mammography use in this sample were similar to those that have been described in younger populations of women. Variables examined because of specific gerontologic considerations were not independently associated with mammography use in the past year.

Barriers to clinical preventive medicine.

The successful integration of preventive services into the primary care setting requires the effective interaction of the patient, physician and health care delivery system. This article defines barriers to preventive service delivery operating at each of these levels and provides an introduction to subsequent articles which address their resolution.

The predictive value of the presenting complaint.

The relationship between the presenting complaint and the principal problem identified during 103 new patient visits was assessed in an academic primary care setting. Complaints and problems were classified by content as somatic, psychosocial, or health maintenance and compared by category. The presenting complaint correctly identified the category in 76 percent of somatic but only 6 percent of psychosocial principal problems (sensitivity of 76 percent and 6 percent, respectively). The likelihood of a same-category principal problem (positive predictive value) ranged from 53 percent for somatic to 100 percent for psychosocial presenting complaints. A specific underlying motivation for the visit other than the presenting complaint was noted by the primary provider in 42 percent of the encounters and was most frequent in those encounters characterized by a lack of concordance between complaint and problem. The presenting complaint introduces the clinical encounter, but its value is limited in specifically identifying the principal problem.

Teenage sexual behaviour: attitudes towards and declared sexual activity.

Although the teenage pregnancy rates in the UK are falling in the 16 to 19 year old range, they are still rising in the 13 to 15 year olds. Overall, they remain one of the highest within Western Europe. Teenagers continue to present a challenge to the health services due to the increase in their sexual risk taking behaviour, the earlier age at which they are starting sexual activity and a reluctance to utilise services available to them. In an attempt to develop current services and make them more 'user friendly', a sexual health needs assessment was carried out on teenagers, part of which looked at their attitudes towards risk taking sexual behaviour and their declared sexual behaviour. A quantitative survey, using a questionnaire in schools, was answered by 1500 pupils aged between 13 and 18 years old, and showed that the majority of teenagers had declared some form of sexual contact with a partner with a degree of sexual activity increasing with age. Twenty per cent of 13 year olds reported that they had already had either full or oral sexual intercourse with a partner. Feeling peer pressure, not knowing the facts about sexual risk taking and a declared intent that would increase the likelihood of putting themselves or others at risk sexually were significantly more likely in the younger teenage boys surveyed. This study confirms that there remain many different factors involved in teenagers' decision-making processes, about their developing attitudes towards sex and their resultant behaviour. Despite a lack of maturity, such opinions and attitudes are bringing about definite views and sexual behaviour patterns in teenagers as young as 12 or 13 years old who are becoming fully sexually active. In particular teenage boys are becoming fully sexually active at a younger age than the girls and are taking risks in doing so. They are being influenced by peer pressure, condoning promiscuity and are declaring the intent to practice unsafe sexual intercourse. Their level of maturity would appear to be inadequate for them to comprehend the implications and consequences of their actions. This study has shown a need for developing adequate education and provision of sexual health services for teenagers, particularly for teenage boys, and that this may go some way in helping to address the imbalances found.

PIP: A needs assessment conducted by the Barking and Havering Health Authority (England) focused on the sexual attitudes and behaviors of British adolescents. 1500 young people 13-18 years old completed a questionnaire. 78% of respondents reported some form of sexual contact with a partner and 23% had experienced sexual intercourse. 38% of male respondents and 11% of females indicated that their peers pressured them to regard sex as the most important thing in a relationship. 10% of teens indicated they would be embarrassed to suggest condom use to a partner and 37% were concerned about appearing clumsy when using a condom. 23% of males and 9% of females claimed they would be willing to have sexual intercourse without use of a condom, despite awareness of the risks involved. Sexually active youth under 16 years old were significantly less likely to use condoms than their older counterparts. Although these findings suggest that teenage boys are at especially high risk of sexual promiscuity and non-use of contraception, service provision remains focused on teenage girls.

The early detection of cancer in the primary-care setting: factors associated with the acceptance and completion of recommended procedures.

Effective cancer control efforts in the primary-care setting require that patients accept and are able to complete recommended early detection procedures. We thus assessed the extent to which procedure nonacceptance or noncompletion limited accomplishment of detection procedures offered as components of routine health care. We also examined the relationship of provider and patient factors to successful procedure accomplishment. Of 221 patients offered procedures by their primary-care provider, 58 (27%) initially declined at least one recommendation, with acceptance rates ranging from 98% for breast exam to 59% for sigmoidoscopy. Furthermore, only 50% of patients offered stool occult blood testing or sigmoidoscopy, 61% offered mammography, and 69% offered Pap smear were able to complete the procedures. Pap smear and mammography were more likely to be initially accepted by those patients with more years of formal education and were less likely to be completed by those with private insurance coverage. Among a subgroup of 76 patients completing a telephone interview, personal health beliefs were not consistently associated with procedure acceptance or completion. These results suggest that both the initial nonacceptance of procedures and the subsequent barriers to their completion limit the efficacy of cancer screening efforts in the primary-care setting. Future research will be required to develop an explanatory model or to propose a targeted intervention.

The acceptance and completion of mammography by older black women.

We assessed the relation of patient characteristics, knowledge and beliefs to the utilization of mammography in an inner-city setting by 187 Black women over the age of 50. Thirty per cent of those who were offered mammography initially declined the offer and 40 per cent were subsequently unable to complete the procedure. Patient interviews were used to derive 27 potential knowledge and health belief predictor scales. In multiple regression analysis, two health belief scales and two knowledge scales accounted for 15 per cent of the observed variance in the model of acceptance. The strongest predictor of subsequent completion was initial acceptance. The presence of breast symptoms and two health belief scales together with initial acceptance accounted for 26 per cent of variance in the model of completion. These results suggest that the successful accomplishment of mammography requires coordinated efforts at the level of the provider, patient, and setting. Health beliefs may influence the patient's behavior in this process, but their effect appears to be modest.

Promoting screening mammography in inner-city settings. The sustained effectiveness of computerized reminders in a randomized controlled trial.

OBJECTIVES: The authors conducted a randomized controlled trial to evaluate the sustained effectiveness of a computerized reminder system in promoting mammography during a second year of continuing intervention at three primary care practices of a Health Department and a health maintenance organization in Detroit, Michigan. METHODS: Out-of-pocket mammography cost was eliminated for all participants (limited intervention). Computer-generated reminders promoting physician referral for mammography were placed in the medical records of women due for mammography 1 month in advance of their due date (full intervention). RESULTS: Among 1,225 year 2 visitors, mammography rates were 44% for full intervention versus 28% for limited intervention at the health department (adjusted odds ratio [OR] for effect of full intervention 1.84; 95% confidence interval [CI]: 1.40-2.40) and 45% for full versus 46% for limited at the health maintenance organization (adjusted OR 1.06; 95% CI 0.80-1.42). These second year results contrasted with those observed for year 1, during which a significant effect of full intervention was demonstrated for both organizations. After controlling for patient characteristics and site, the effect sizes of full intervention were reduced significantly in the second year compared with the first year (P = 0.05). CONCLUSIONS: The effect of computerized mammography reminders can be sustained in a second year of continued intervention, but individual practice sites and organizations vary in their responsiveness to the intervention. Strategies to promote periodic and repetitive procedure use must identify and address time-varying barriers to their effectiveness.

Cardiovascular risk factors and obesity: are baseline levels of blood pressure, glucose, cholesterol and uric acid elevated prior to weight gain?

The increased risk of cardiovascular morbidity and mortality experienced by the obese may be partially mediated through alterations induced in other associated risk factors. The attribution of this cardiovascular risk to obesity presumes that levels of those risk factors are not elevated independently of, or prior to, weight gain. We therefore examined baseline levels of blood pressure, glucose, cholesterol, and uric acid within age and sex specific strata of a population of 4015 individuals followed an average of 15 years to determine if an increasing level of fatness (weight/height 2) at follow-up was associated with elevation of other risk factors at baseline. After controlling for baseline fatness we were unable to demonstrate any consistent relationship between future fatness and baseline elevation of any of the factors. The magnitude of the partial correlation coefficients for those age 6-24 or 25-65 years at baseline were less than 0.11 for all of the risk factors. While a metabolic predisposition may link obesity to alterations of other risk factors it appears unlikely that their elevation commonly precedes weight gain. A pre-existing elevation of risk factors has not resulted in the misattribution of cardiovascular risk to obesity.

Health status and mammography use among older women.

OBJECTIVE: To assess the extent to which an age-associated reduction in mammography use can be explained by declining self-reported health status. DESIGN: We analyzed data from the 1992 National Health Interview Survey (NHIS) and Cancer Control Supplement. Logistic regression analysis was used to evaluate the association between age, health status (self-reported health and limitations in major activity), and other variables potentially related to mammography use within the past 1 year (recent mammography). PARTICIPANTS: Of 12,035 NHIS respondents we restricted our analysis to the 1,772 women aged 50 years or older who reported one or more lifetime mammograms. We excluded women without a mammogram (n = 937) because we were interested in factors related to recent use versus past use of mammography. MEASUREMENTS AND MAIN RESULTS: The percentage of women with a recent mammogram declined with increasing age, and the age association was independent of other factors including health status (adjusted odds ratio [OR] comparing women aged 75 years or older with those aged 50 to 64 years was 0.54; 95% confidence interval [CI] 0.41, 0.70). This age effect persisted in an analysis restricted to women reporting good or better health (adjusted OR was 0.60, 95% CI 0.44, 0.80). CONCLUSION: The observed decline in recent mammography use with advancing age was not explained by variation in health status. Because healthy elderly women may live long enough to realize the potential benefit of screening mammography, factors responsible for its reduced use should be identified. Doing so will allow for the selective promotion of screening mammography among those older women most likely to benefit.

A randomized design for repeated binary outcomes used to evaluate continued effectiveness of a breast cancer control intervention strategy.

The literature has not discussed in detail design and evaluation strategies for the assessment of continued effectiveness of intervention strategies. In this article we present an approach to evaluating continued effectiveness with two repeated binary outcomes that are related to the use of preventive services. We present a two-stage design with independent randomization procedures for each of two successive controlled trials and discuss the implications of the randomization plan for the statistical evaluation. Intervention effectiveness for each year is determined by an adjusted odds ratio that compares the odds of procedure use for those who received the intervention to those who did not. Changes in the two adjusted odds ratios between successive years are assessed within the context of a regressive logistic model. We demonstrate these methods by applying them to the Metropolitan Detroit Project to Reduce Avoidable Mortality from Breast Cancer. In this project, computer-generated physician mammography reminders placed prominently in medical records were used to promote mammography referrals among women visiting primary care clinics during a 2-year intervention period. An assessment of the change in intervention effectiveness as well as an adjusted estimate of the overall intervention effectiveness for the 2 years were obtained from a multivariate regressive logistic model. The advantage of this approach was its potential for reducing bias and producing a balanced comparison between intervention groups during the second year of intervention. This issue was important because previous work indicated that having had a mammogram had a significant impact on subsequent mammography use. An important component in the implementation of this design was an information management system that facilitated doing two randomization procedures efficiently. As information and computer technology advance, and as more sophisticated information systems are used for data management, designs such as these become reasonable alternatives to consider.

Promoting screening mammography in inner-city settings: a randomized controlled trial of computerized reminders as a component of a program to facilitate mammography.

In a one-year randomized controlled trial, we assessed the effectiveness of a computerized mammography reminder system as a component of a program to increase the use of screening mammography in three health care organizations serving inner-city women in Detroit, Michigan (two sites of a health department, one HMO site, and two sites of a private hospital). Four thousand four hundred and one women older than 40 who had visited a study site in the preceding year were randomly assigned to one of two treatment groups. Limited intervention (LI) included physician and staff breast cancer control education, facilitated mammography appointment scheduling procedures, and elimination of out-of-pocket patient cost for mammography (at three of five sites). Full intervention (FI) included all components of limited intervention plus an additional series of "cues-to-action." These included a mammography reminder form inserted in the medical record of women who were due to have mammography, intended to increase physician referral for mammography appointments, and patient reminders intended to increase completion of mammography among referred women. During the one-year intervention period 2,725 randomized women visited a study site. The 6-month mammography appointment rates among FI women vary from 38% to 65% and the FI rate exceeds the LI rate at each site with differences from 13% (95% CI, 6 to 20) to 29% (21 to 38). The annual completed mammography rate among FI women extends from 43% to 64% and exceeds the LI rate at each site by 12% (5 to 19) to 25% (16 to 34). After age-adjustment, the mammography intervention effect sizes among the five sites were not significantly different. The average increase in FI compared to LI was 18%. The computerized reminder system is effective in increasing the use of mammography in each of the study institutions and the major effect is on physician referral for mammography.