The relative contribution of patient, provider and organizational influences to the appropriate diagnosis and management of diabetes mellitus.

OBJECTIVE: To estimate the relative contribution of patient attributes, provider characteristics and organizational features of the doctors' workplace to the diagnosis and management of diabetes. RESEARCH DESIGN AND METHODS: In a factorial experimental design doctors (n = 192) viewed clinically authentic vignettes of 'patients' presenting with identical signs and symptoms. Doctor subjects were primary care doctors stratified according to gender and level of experience. During an in-person interview scheduled between real patients, doctors were asked how they would diagnosis and manage the vignette 'patients' in clinical practice. RESULTS: This study considered the relative contribution of patient, doctor and organizational factors. Taken together patient attributes explained only 4.4% of the variability in diabetes diagnosis. Doctor factors explained only 2.0%. The vast majority of the explained variance in diabetes diagnosis was due to organizational factors (14.3%). Relative contributions combined (patient, provider, organizational factors) explained only 20% of the total variance. CONCLUSION: Attempts to reduce health care variations usually focus on the education/activation of patients, or increased training of doctors. Our findings suggest that shifting quality improvement efforts to the area which contributes most to the creation and amplification of variations (organizational influences) may produce better results in terms of reduced variations in health care associated with diabetes.

Work stress of primary care physicians in the US, UK and German health care systems.

Work-related stress among physicians has been an issue of growing concern in recent years. How and why this may vary between different health care systems remains poorly understood. Using an established theoretical model (effort-reward imbalance), this study analyses levels of work stress among primary care physicians (PCPs) in three different health care systems, the United States, the United Kingdom and Germany. Whether professional autonomy and specific features of the work environment are associated with work stress and account for possible country differences are examined. Data are derived from self-administered questionnaires obtained from 640 randomly sampled physicians recruited for an international comparative study of medical decision making conducted from 2005 to 2007. Results demonstrate country-specific differences in work stress with the highest level in Germany, intermediate level in the US and lowest level among UK physicians. A negative correlation between professional autonomy and work stress is observed in all three countries, but neither this association nor features of the work environment account for the observed country differences. Whether there will be adequate numbers of PCPs, or even a field of primary care in the future, is of increasing concern in several countries. To the extent that work-related stress contributes to this, identification of its organizational correlates in different health care systems may offer opportunities for remedial interventions.

Frailty, serum androgens, and the CAG repeat polymorphism: results from the Massachusetts Male Aging Study.

CONTEXT: The CAG repeat polymorphism in the androgen receptor, denoted (CAG)n, is thought to (inversely) index androgen sensitivity. We hypothesized that (CAG)n would exhibit a modifying influence on the association between circulating total and calculated free testosterone (TT and FT) and physical frailty in aging men. OBJECTIVE: The objective of the study was to establish the influence of (CAG)n on the relation between circulating TT, FT, LH, SHBG, and frailty. DESIGN: This was a prospective cohort study of health and endocrine functioning in randomly selected men, with a baseline (T1: 1987-89) and two follow-up (T2: 1995-1997; T3: 2002-2004) visits. SETTING: This was an observational study of men residing in greater Boston, MA. PARTICIPANTS: A total of 624 subjects aged 50-86 yr were retained. MAIN OUTCOME MEASURES: The frailty phenotype was measured at T3. Components included weight loss, exhaustion, low physical activity, weakness, and slowness. Subjects exhibiting two of these five components were considered to be in an intermediate state, and those exhibiting three or more were considered frail. RESULTS: (CAG)n was positively associated with TT and FT. Multivariable regression analyses revealed no influence of CAG on longitudinal within-subject changes in hormone levels or cross-sectional (T3) associations between hormone concentrations and the prevalence of intermediate frailty or frailty. Models incorporating subjects' history of hormone decline produced similar negative results. CONCLUSIONS: This population-based study does not support the hypothesis that interindividual differences in (CAG)n can account for a lack of association between circulating androgens and the frailty phenotype. Longitudinal analyses are needed to confirm these conclusions.

Society of vascular surgery vascular registry comparison of carotid artery stenting outcomes for atherosclerotic vs nonatherosclerotic carotid artery disease.

OBJECTIVE: The Vascular Registry (VR) on carotid procedures collects long-term outcomes on carotid artery stenting (CAS) and carotid endarterectomy (CEA) patients. The purpose of this report is to describe in-hospital and 30-day CAS outcomes in patients with atherosclerotic carotid artery disease (CAD; atherosclerosis [ATH]) compared to recurrent carotid stenosis (RES) and radiation-induced stenosis (RAD). METHODS: The VR collects provider-reported data on CAS using a Web-based data management system. For this report, data were analyzed at the preprocedure, procedure, predischarge, and 30-day intervals. RESULTS: As of November 20, 2008, there were 4017 patients with CAS with discharge data, of which 72% were due to ATH. A total of 2321 patients were available for 30-day outcomes analysis (1623 ATH, 529 restenosis, 119 radiation, 17 dissection, 3 trauma, and 30 other). Baseline demographics showed that ATH occurred in older patients (72-years-old), had the greatest history of coronary artery disease (CAD; 62%), myocardial infarction (MI; 24%), valvular heart disease (8%), arrhythmia (16%), congestive heart failure (CHF; 16%), diabetes mellitus (DM; 35%), and chronic obstructive pulmonary disease (COPD; 20%). RES had a higher degree of baseline stenosis (87.0 vs 85.8 ATH; P = .010), were less likely to be symptomatic (35.5% vs 46.3% ATH; P < .001), but had a greater history of hypertension, peripheral vascular disease (PVD), and smoking. RAD was seen in younger patients (66.6 vs 71.7 ATH; P < .001), were more likely to be male (78.2% vs 60.9% ATH; P < .001), and had less comorbidities overall, with the exception of amaurosis fugax, smoking, and cancer. The only statistically significant difference in perioperative rates was in transient ischemic attack (TIA; 2.7% ATH vs 0.9% RES; P = .02). There were no statistically significant differences in in-hospital death/stroke/MI (ATH 5.4%, RES 3.8%, RAD 4.2%) or at 30 days (ATH 7.1%, RES 5.1%, RAD 5.0%). Even after adjusting for age, gender, symptomatology, CHF, and renal failure, the only statistically significant difference at 30 days was amaurosis fugax between ATH and RAD (odds ratio [OR] 0.13; P = .01). CONCLUSION: Although patients with ATH have statistically significant comorbidities, they did not have statistically significant increased rates of death/stroke/MI during hospitalization or within 30 days after discharge when compared to RES or RAD. The CAS event rates for ATH vs RES and RAD are similar, despite prior published reports. Symptomatic ATH have statistically significant higher rates of death/stroke/MI compared to asymptomatic cohort. Finally, consistent and accurate entry of long-term data beyond initial hospitalization is essential to fully assess CAS outcomes since a significant number of adverse events occur in the interval from hospital discharge to 30 days.

It's about time: physicians' perceptions of time constraints in primary care medical practice in three national healthcare systems.

BACKGROUND: As physicians are pressured to deliver an increasing number of preventive services, follow guidelines, engage in evidence-based practice, and deliver patient-centered care in managerially driven organizations, they struggle with how much control they have over their time. METHODS: A secondary analysis was conducted with data from 3 parallel studies of clinical decision making in Germany, the United Kingdom, and the United States with 128 physicians per country. Physicians reported how much time they were allocated and how much time they needed for high-quality care for new patient appointments, routine consultations, and complete physicals. They also reported how much control they had over their time in the office and spending adequate time with patients. RESULTS: German, British, and American physicians were allocated (on average) 16/11/32 minutes for a new patient appointment, 6/10/18 minutes for a routine visit, and 12/20/36 minutes for a complete physical, but felt that they needed more time. Over half of German and American physicians felt that they always or usually had control over the hours they were required to be in their office or spending sufficient time with their patients while less than half of British physicians felt this way. CONCLUSION: German physicians had the least time allocated and needed for most types of appointment. American physicians had the most time allocated and needed for each type of appointment. However, British physicians felt they had the least control over time in their office and spending sufficient time with patients.

Sexual activity, erectile dysfunction, and incident cardiovascular events.

Although erectile dysfunction (ED) is considered a well-established risk factor for cardiovascular disease (CVD), few studies have investigated whether other aspects of sexual function might predict CVD independently of ED. In a longitudinal, population-based study of community-dwelling men participating in the Massachusetts Male Aging Study, we examined sexual function variables (including ED) and the subsequent development of CVD. ED was defined according to a validated, discriminant-analytic formula determined from the questionnaire responses and categorized as moderate/complete ED versus none/minimal. CVD included a wide range of major end points and was ascertained through self-report, medical records, and the National Death Index. We calculated the age-adjusted incidence rates according to the person-years of follow-up, and Cox proportional hazards models were used to estimate covariate-adjusted, Framingham risk score-adjusted, and ED-adjusted hazard ratios and 95% confidence intervals for sexual function variables and the subsequent risk of CVD. Of the 1,165 men free of CVD at baseline, the age-adjusted CVD incidence rate for moderate/complete ED and none/minimal ED was 17.9/1,000 person-years and 12.5/1,000 person-years, respectively. In multivariate models adjusted for age, covariates, ED, and the Framingham risk score, a low frequency of sexual activity (once a month or less vs >or=2 times weekly) was associated with increased risk of CVD (hazard ratio 1.45, 95% confidence interval 1.04 to 2.01). In conclusion, our results suggest that a low frequency of sexual activity predicts CVD independently of ED and that screening for sexual activity might be clinically useful.

Risk factors for incident erectile dysfunction among community-dwelling men.

INTRODUCTION: Compared to the prevalence of erectile dysfunction (ED), fewer studies have focused on the incidence of ED and even fewer have focused on nonmedical risk factors. AIM: We examined psychosocial, demographic/socioeconomic, medical/behavioral, and sexual function risk factors at T1 (1987-1989) and development of incident ED at T2 (1995-1997). METHODS: Longitudinal population-based epidemiologic study of 814 community-dwelling men participating in the Massachusetts Male Aging Study. MAIN OUTCOME MEASURE: ED was defined according to a validated, discriminant-analytic formula based on questionnaire responses and categorized as moderate/complete ED vs. none/minimal. Multivariate logistic regression models (odds ratios [ORs] and 95% confidence intervals [CI]) were used to estimate the association of risk factors with ED. RESULTS: Among 814 men free of ED at T1, 22% developed moderate/complete ED at T2 (on average, approximately 8.8 years later). In a multivariate model, sexual function variables captured at baseline were inversely associated with ED (e.g., more or similar level of sexual arousal compared to adolescence vs. less, OR = 0.56, 95% CI: 0.34, 0.92; frequency of sexual thoughts at least two to three times weekly vs. less, OR = 0.55, 95% CI: 0.33, 0.92) after adjustment for age, education, and other risk factors. CONCLUSIONS: Our results indicate that in the context of other risk factors, sexual desire variables at baseline were associated with incident ED. This in turn suggests that indications of reduced function appear earlier than ED itself, and that there may be a time window for intervention before a loss of erectile function.

Carotid revascularization using endarterectomy or stenting systems (CaRESS): 4-year outcomes.

PURPOSE: To examine the 4-year outcomes from Carotid Revascularization using Endarterectomy or Stenting Systems (CaRESS) in light of the current reimbursement guidelines for carotid artery stenting (CAS) from the Centers for Medicare and Medicaid Services (CMS). METHODS: CaRESS was designed as a prospective, nonrandomized comparative cohort study of a broad-risk population of symptomatic and asymptomatic patients with carotid stenosis. In all, 397 patients (247 men; mean age 71 years, range 43-89) were enrolled and underwent carotid endarterectomy (CEA; n = 254) or protected CAS (n = 143). More than 90% of patients had >75% stenosis; two thirds were asymptomatic. The primary endpoints included (1) all-cause mortality, (2) any stroke, and (3) myocardial infarction (MI), as well as the composite endpoints of (4) death and any nonfatal stroke and (5) death, nonfatal stroke, and MI. The secondary endpoints were restenosis, repeat angiography, and carotid revascularization. All patients were classified with respect to surgical risk, symptom status, and stenosis grade based on criteria published by the CMS. In addition, separate analyses were performed comparing genders and octogenarians to those <80 years old. RESULTS: No significant differences in the primary outcome measures were found between the CEA and CAS groups in the 4-year analysis. The incidences of any stroke at 4 years were 9.6% for CEA and 8.6% for CAS (p = 0.444); when combined with death, the composite death/nonfatal stroke rates were 26.5% for CEA versus 21.8% for CAS (p = 0.361). The composite endpoint of death, nonfatal stroke, and MI at 4 years was 27.0% in CEA versus 21.7% in CAS (p = 0.273) patients. The secondary endpoints of restenosis (p = 0.014) and repeat angiography (p = 0.052) were higher in the CAS arm. There were no differences in any of the subgroups stratified according the CMS guidelines or in the gender comparison. Four-year incidences of death/nonfatal stroke and death/nonfatal stroke/MI were higher in the CEA arm among patients <80 years of age (p = 0.049 and p = 0.030, respectively). There were no significant differences between these incidences in the octogenarian subgroup. CONCLUSION: The risk of death or nonfatal stroke 4 years following CAS with distal protection is equivalent to CEA in a broad category of patients with carotid stenosis. There were no significant differences in stroke or mortality rates between high-risk and non-high-risk patients and no differences in outcomes between symptomatic and asymptomatic patients. After 4 years, CAS had a 2-fold higher restenosis rate compared to CEA. The risk of death/stroke or death/stroke/MI appears to be higher following CEA than CAS among patients <80 years of age, yet there is no statistically significant relationship between death, stroke, or MI among octogenarians.

Does the culture of a medical practice affect the clinical management of diabetes by primary care providers?

OBJECTIVES: The financing and organization of primary care in the United States has changed dramatically in recent decades. Primary care physicians have shifted from solo practice to larger group practices. The culture of a medical practice is thought to have an important influence on physician behavior. This study examines the effects of practice culture and organizational structure (while controlling for patient and physician characteristics) on the quality of physician decision-making. METHODS: Data were obtained from a balanced factorial experiment which employed a clinically authentic video-taped scenario of diabetes with emerging peripheral neuropathy. RESULTS: Our findings show that several key practice culture variables significantly influence clinical decision-making with respect to diabetes. Practice culture may contribute more to whether essential examinations are performed than patient or physician variables or the structural characteristics of clinical organizations. CONCLUSIONS: Attention is beginning to focus on physician behavior in the context of different organizational environments. This study provides additional support for the suggestion that organization-level interventions (especially focused on practice culture) may offer an opportunity to reduce health care disparities and improve the quality of care.

The intended and unintended consequences of clinical guidelines.

OBJECTIVES: First, we examine whether clinical guidelines, designed to improve health care and reduce disparities in clinical practice, are achieving their intended consequences. Second, we contemplate potential unintended consequences of clinical guidelines. METHOD: As part of a factorial experiment we presented primary care doctors (n = 192) with clinically authentic vignettes of a 'patient' with already diagnosed diabetes with an emerging foot neuropathy. Their proposed clinical actions were compared with established practice guidelines for this clinical situation. RESULTS: After establishing the existence of consistent socioeconomic disparities in the proposed management of the case presented, we found that reported use of practice guidelines had no measurable effect towards their reduction (one intended consequence). However, the reported use of practice guidelines appeared to precipitate more clinical actions, without eliminating documented disparities. CONCLUSIONS: Consistent with other research we find that clinical practice guidelines are not producing a principal intended result, and may even produce unintended consequences.

Lifeline registry of endovascular aneurysm repair: open repair surgical controls in clinical trials.

PURPOSE: The improvement of available endovascular aortic aneurysm repair (EVAR) devices is critical for the advancement of patient care in vascular surgery. The goal of this article is to report a highly detailed, closely monitored, audited, pooled multicenter cohort of open surgical abdominal aortic aneurysm (AAA) repairs that has potential for use in future EVAR studies as a control data set. METHODS: Open surgical AAA repair data from four investigational device exemption clinical aortic endograft trials were tested for poolability, merged, and analyzed for the intervals of 0 to 30 days and 31 to 365 days. RESULTS: The data set includes 323 open patients (83% men; mean age, 70 years). Operative mortality at 30 days was 2.8%. The mean age of women was 3 years older than men, and mortality at 30 days for women was 5.7% compared with 2.2% for men (P = .18). Operative mortality for patients with large AAAs (>/=5.5 cm, 3.6%) was not different than for patients with small aneurysms (<5.5 cm, 2.4%, P = .54). All-cause mortality at 1 year was 6.7%, with significant predictors including age, sex, and renal failure. Women had 2.6-fold greater 1-year all-cause mortality rate (13.2%) than men (5.4%, P = .04), but statistical significance was lost after correction for age. Two additional AAA-related deaths occurred between days 31 and 365, resulting in a 1-year AAA-related mortality of 3.5%. CONCLUSION: This data set provides a tightly controlled, thoroughly detailed, and audited experience that has the potential to serve as an open control group for future EVAR trials.

A multiple marker model to predict pregnancy viability when progesterone is indeterminate.

OBJECTIVE: To develop a model to differentiate viable from nonviable pregnancies at a single first-trimester visit. STUDY DESIGN: This prospective cohort study included 256 symptomatic women in the first trimester who presented to our urgent care unit in Providence, Rhode Island, between 2002 and 2004. Predictors of pregnancy viability were collected, including clinical information and serum samples for several biomarkers. Each predictor was evaluated alone and in conjunction with other variables using receiver operator characteristic curves. The cohort was separated into 2 subgroups based on whether the progesterone value was at the "extremes" (<5 ng/mL or >25 ng/mL) or in the "grey zone" (5-25 ng/mL). RESULTS: Among single biomarkers, progesterone had the greatest diagnostic accuracy in predicting viability. Progesterone was highly accurate at the extremes (area under the curve [AUC] = 0.99) but less accurate in the grey zone (AUC = 0.71). A multiple marker model was developed to include progesterone for all patients, and human chorionic gonadotropin, ultrasound findings and symptoms for participants in the grey zone (AUC = 0.90). CONCLUSION: A multiple marker model predicted pregnancy viability in symptomatic women with overall accuracy of 90%.

The natural history of symptomatic androgen deficiency in men: onset, progression, and spontaneous remission.

OBJECTIVES: To describe the onset, progression, and remission of symptomatic androgen deficiency (SAD) using longitudinal data from the Massachusetts Male Aging Study (MMAS). DESIGN: A prospective, population-based study of men living in Boston, Massachusetts. Data were collected in three waves: T1 (1987/89), T2 (1995/97), T3 (2002/04). Onset, progression, and remission were defined in terms of transitions in SAD status from one wave to the next. SETTING: In-person, in-home interviews. PARTICIPANTS: Seven hundred sixty-six community-dwelling men aged 40 to 70 at baseline (T1) contributed data from T1 to T2 and 391 from T2 to T3. MEASUREMENTS: SAD was defined in terms of serum total and free testosterone (T) levels and symptoms associated with low circulating androgens. Total T and sex hormone-binding globulin (SHBG) were measured using radioimmunoassay. Free T was calculated from total T and SHBG measurements. RESULTS: At T2 or T3, the likelihood of SAD was markedly greater for subjects who had exhibited SAD at the previous wave (odds ratio=3.8, 95% confidence interval=1.9-7.4), overall 55% of subjects who exhibited SAD experienced remission by the next study wave. The probability of SAD was greater with older age and greater body mass index. Multivariate models demonstrated that the likelihood of remission was at least 50% for most subpopulations. CONCLUSION: Over approximately 15 years of follow-up, SAD did not represent a stable health state. The likelihood of SAD would remit exceeded the likelihood that it would not, particularly among younger and leaner men.

Ultrasound-guided miduterine cavity embryo transfer is associated with a decreased incidence of retained embryos in the transfer catheter.

After initiating a policy of ultrasound-guided miduterine cavity embryo transfer (ET) on August 1, 2001, the incidence of retained embryos in the transfer catheter declined significantly from 4.2% (46 of 1,101 ETs) during the time interval January 1, 2000 to July 31, 2001, to 0.7% (6 of 908 ETs) during the time interval August 1, 2001 to December 31, 2002. Blood on the transfer catheter (38% vs. 19%) occurred with significantly greater frequency at ET in which embryos were retained; ETs of > or =4 embryos were more likely to be associated with retained embryos than ETs of <4 embryos (3.7% vs. 2.2%), and both the clinical pregnancy rate (PR) and implantation rate (IR) were lower when embryo retention occurred at ET than they were when embryos were not retained (25% vs. 34% clinical PR; 12% vs. 19% IR).

A randomized trial of the Fischer cone biopsy excisor and loop electrosurgical excision procedure.

OBJECTIVE: To compare specimens obtained with the Fischer cone biopsy excisor or loop electrosurgical excision procedure (LEEP) with respect to number of specimens obtained, margin interpretability, adequacy of excision, and ease of use. METHODS: One hundred eligible patients aged 13 years and older were randomly assigned to treatment with the Fischer cone biopsy excisor or LEEP. Eligibility criteria included: (1) cervical intraepithelial neoplasia (CIN) 2 or 3, (2) persistent CIN 1, or (3) cytologic/histologic discrepancy. Following excision, providers ranked ease of use on a scale of 1 to 10. A pathologist blinded to procedure type analyzed specimens for margin interpretability and adequacy of excision. Before study initiation we calculated that a total of 100 patients would be required to demonstrate a significant difference in the interpretable margin rate of 80% for LEEP and 99% for cone biopsy excisor (power 80%, alpha =.05). RESULTS: After adjustment for ease of use, lesion size, and degree of neoplasia, the cone biopsy excisor was no more likely to result in a single specimen than LEEP (74% versus 63%, relative risk [RR] 0.93, 95% confidence interval [CI] 0.79 -1.11), to result in a specimen with interpretable margins (65% versus 73%, RR 0.97, 95% CI 0.78-1.22), or to result in a fully excised cervical lesion (72% versus 62% for LEEPs, RR 1.08, 95% CI 0.77-1.52). Providers found their experiences with both Fischer cone biopsy excisor and LEEP cone biopsies to be similar, even after adjustment for year of training and previous experience (RR 0.95, 95% CI 0.72-1.24). CONCLUSION: The Fischer cone biopsy excisor and LEEP performed similarly with respect to the number of final specimens, margin interpretability, and ease of use. LEVEL OF EVIDENCE: I