Variation in Radiotherapy Referral and Treatment for High-risk Pathological Features after Radical Prostatectomy: Results from a Population-based Study.

AIMS: Guidelines recommend the discussion of adjuvant radiotherapy post-prostatectomy for prostate cancer patients with high-risk pathology to consider all of their treatment options. We determine whether patterns of radiotherapy referral and treatment post-prostatectomy reflect guideline-based use in a contemporary prostatectomy cohort. MATERIALS AND METHODS: Electronic treatment records were linked to Ontario's cancer registry. Multivariable regression was used to evaluate clinical and health systems factors associated with referral and the use of adjuvant radiotherapy within 6 months post-prostatectomy. RESULTS: Among 2663 patients treated with prostatectomy between 1 January 2012 and 30 November 2012, 1261 (47%) were found to have adverse pathology and 492 were referred to radiation oncology ≤6 months post-prostatectomy, of whom 51% received adjuvant radiotherapy. Multivariable analysis showed that patients were more likely to be referred to radiation oncology from a low-volume surgical facility (≤50 versus >50 radical prostatectomy cases, odds ratio 2.50 [1.80-3.48]), if they lived farther from a radiotherapy centre (>50 km versus <10 km, odds ratio 1.73 [1.22-2.46]), if they were seen by radiation oncology preoperatively (odds ratio 1.95 [1.51-2.52]), or if they had adverse pathology: high T-category (pT3b/T4 versus pT2, odds ratio 17.87 [12.14-26.30]; pT3a versus pT2, odds ratio 5.24 [3.95-6.97]), positive margins (non-apex positive versus negative, odds ratio 4.20 [3.19-5.53]; apex only positive versus negative, odds ratio 2.60 [1.71-3.94]) and high Gleason score (8-10 versus ≤6, odds ratio 11.32 [5.37-23.84]; 7 versus ≤6, odds ratio 4.18 [2.16-8.10]). Wide geographic variation in radiotherapy referral rates persisted (range 6-66%; P < 0.0001). After radiotherapy referral, only high T-category (pT3b/T4 versus pT2, odds ratio 5.37 [3.01-9.60]; pT3a versus pT2, odds ratio 2.72 [1.59-4.65]) and non-apex positive margins (odds ratio 2.81 [1.86-4.23]) remained significantly predictive of treatment. CONCLUSIONS: Variations in referral for a discussion of radiotherapy post-prostatectomy are not mainly explained by patient characteristics. After seeing radiation oncology, treatment decisions correlated most strongly with pathological findings. Understanding the reasons for the tremendous non-clinical variations in care is needed to ensure access to potentially curative radiotherapy post-prostatectomy for high-risk prostate cancer patients.

Quality of Radiation Therapy Referral and Utilisation Post-prostatectomy: A Population-based Study of Time Trends.

AIMS: Adjuvant radiotherapy post-prostatectomy has been shown to benefit patients with adverse pathology. It remains unclear whether salvage radiotherapy confers equivalent outcomes. Practice guidelines recommend referral to radiation oncology within 6 months after prostatectomy to discuss adjuvant and salvage radiotherapy. The study objectives were to assess, at a population level: (i) post-prostatectomy referral patterns for radiotherapy; (ii) adjuvant and salvage radiotherapy utilisation; and (iii) time trends in relation to clinical trials and guidelines. These findings provide indications of access to quality care. MATERIALS AND METHODS: This was a retrospective cohort study. Electronic radiotherapy consultation and treatment records were linked to the population-based Ontario Cancer Registry. The population included prostate cancer cases treated with prostatectomy in Ontario between 2003 and 2012. Radiotherapy referral and treatment rates over time were analysed using the chi-squared trend test. RESULTS: Over the study period, 30 447 prostate cancer patients received prostatectomy. The proportion seen by radiation oncology within 6 months after prostatectomy doubled from 10.7% in 2003-2004 to 21.7% in 2011-2012 (P < 0.0001 for trend), with the largest annual percentage difference in 2009-2011 (3.4%). Among 4641 patients seen within 6 months, adjuvant radiotherapy rates remained at 51.0% ± 3.0%. Contemporaneous with radiation oncology referral trends, overall adjuvant radiotherapy use increased from 6.2% in 2003-2004 to 11.0% in 2011-2012 (P < 0.001), while salvage radiotherapy remained at 8.4% ± 0.4%. Consequently, the total proportion receiving radiotherapy within 24 months increased from 14.1% in 2003-2004 to 17.7% in 2009-2010 (P < 0.0001). CONCLUSIONS: There was an increase in access to early radiation oncology referral post-prostatectomy and adjuvant radiotherapy in Ontario between 2003 and 2012, following guideline publication.

Drugs that inhibit gastric acid secretion may alter the course of inflammatory bowel disease.

BACKGROUND: Recent data suggest that acid suppressive medications may alter factors central to the pathophysiology of inflammatory bowel diseases (IBD), whether through shifts in the intestinal microbiome due to acid suppression or effects on immune function. AIM: To assess the relationship between the use of proton pump inhibitors (PPIs) or histamine2-receptor antagonists (H2Ra) and incidence of 'flares' (hospitalisation/surgery and change in medication). METHODS: We conducted a new user cohort study including individuals diagnosed with IBD in British Columbia using linked healthcare utilisation databases (available from July 1996 through April 2006). Propensity-score matched incidence rates during a 6-month follow-up period and rate ratios (RR) and 95% CI were calculated. RESULTS: Among 16 151 IBD patients, 1307 Crohn's disease (CD) and 996 ulcerative colitis (UC) patients experienced a new use of PPIs, whereas 741 CD and 738 UC used H2Ra. All IBD subgroups were matched separately to an equal number of unexposed IBD patients. H2Ra use in CD doubled the risk of hospitalisation/surgery (RR = 1.94; 95%CI 1.24-3.10) and numerically less so in UC patients (RR = 1.11) with widely overlapping CIs (0.61-2.03). Proton pump inhibitors use was associated with medication change in UC (RR = 1.39; 95%CI 1.20-1.62), but without meaningfully, increased risk of hospitalisation/surgery for UC or CD patients. Extending follow-up showed persistence, but attenuation, of all effects. CONCLUSIONS: Initiation of PPIs or H2Ra may be associated with short-term changes in the course of IBD. Although confounding by indication was adjusted using propensity score matching, residual confounding may persist and findings need to be interpreted cautiously.

A simple risk score for predicting surgical site infections in inflammatory bowel disease.

PURPOSE: Patients with inflammatory bowel disease are often at highest risk for surgical site infections. We sought to define the predictors of surgical site infections and to develop a risk score for predicting those at highest risk. METHODS: Patients undergoing a bowel resection for Crohn's disease or ulcerative colitis were identified from National Surgical Quality Improvement Program 2008. Univariate and multivariate analyses were conducted to identify predictors of surgical site infections. Clinically relevant prediction categories were developed and the predictive behavior of the model was validated by use of National Surgical Quality Improvement Program 2007. An integer-based scoring system risk score was created proportional to the logistic regression coefficients, grouping patients into categories of similar risk. RESULTS: We identified 271,368 patients; 3981 of these patients underwent an operation for Crohn's disease (n = 2895) or ulcerative colitis (n = 1086). Nine hundred (22.6%) patients developed surgical site infections. Predictors included weight loss, smoking, emergent surgery, wound class, operative time (minutes), and an ASA score >2. A risk score was developed by stratifying patients into low (0-5), 15.6%; medium (6-8), 25.2%; and high (>8), 36.1% risk. CONCLUSIONS: Patients with inflammatory bowel disease are at high risk for surgical site infections. Preoperative factors including weight loss, smoking, emergent surgery and an ASA score >2 are strong predictors of surgical site infections. Operative time and wound class are important intraoperative predictors. A risk score, based on pre- and intraoperative variables, can be used to identify patients at highest risk of developing surgical site infections. This may allow for appropriate process measures to be implemented to prevent and lessen the impact of surgical site infections in this high-risk population.

Patient satisfaction and health-related quality of life following breast reconstruction: patient-reported outcomes among saline and silicone implant recipients.

BACKGROUND: In recent years, there has been a growing acceptance of the value of breast reconstruction. The majority of women who choose to proceed will undergo alloplastic reconstruction. The primary objective of this study was to determine whether the type of implant used in alloplastic breast reconstruction has an impact on patient-reported satisfaction and quality of life. METHODS: Patients were deemed eligible if they had completed alloplastic reconstruction at least 1 year before study initiation. Patients were contacted by mail: two questionnaires [the BREAST-Q and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Br23) (EORTC QLQC30 (Br23))], a contact letter, and an incentive gift card were included. Scores were compared between silicone and saline implant recipients. RESULTS: Seventy-five silicone implant recipients and 68 saline implant recipients responded, for a response rate of 58 percent. BREAST-Q responses showed silicone implant recipients to have higher scores on all nine subscales. This difference reached statistical significance on four of nine subscales: overall satisfaction (p = 0.008), psychological well-being (p = 0.032), sexual well-being (p = 0.05), and satisfaction with surgeon (p = 0.019). Regression analysis adjusted for follow-up time, timing of surgery, unilateral versus bilateral surgery, radiation, and age. Results from the EORTC QLQC30 (Br23) showed a statistically significant difference on two of 22 subscales: silicone recipients had higher overall physical function, and saline recipients had higher systemic side effects. CONCLUSIONS: This study has shown higher satisfaction with breast reconstruction in silicone gel implant recipients compared with saline recipients using the BREAST-Q. There was no difference in overall global health status between the two patient groups as measured by the EORTC-QLQC30 (Br23).

Health literacy not race predicts end-of-life care preferences.

BACKGROUND: Several studies have reported that African Americans are more likely than whites to prefer aggressive treatments at the end of life. OBJECTIVE: Since the medical information presented to subjects is frequently complex, we hypothesized that apparent differences in end-of-life preferences and decision making may be due to disparities in health literacy. A video of a patient with advanced dementia may overcome communication barriers associated with low health literacy. DESIGN: Before and after oral survey. PARTICIPANTS: Subjects presenting to their primary care doctors. METHODS: Subjects were asked their preferences for end-of-life care after they heard a verbal description of advanced dementia. Subjects then viewed a 2-minute video of a patient with advanced dementia and were asked again about their preferences. For the analysis, preferences were dichotomized into comfort care and aggressive care. Health literacy was measured using the Rapid Estimate of Adult Literacy in Medicine (REALM) and subjects were divided into three literacy categories: low (0-45, sixth grade and below), marginal (46-60, seventh to eighth grade) and adequate (61-66, ninth grade and above). Unadjusted and adjusted logistic regression models were fit using stepwise algorithms to examine factors related to initial preferences before the video. RESULTS: A total of 80 African Americans and 64 whites completed the interview. In unadjusted analyses, African Americans were more likely than whites to have preferences for aggressive care after the verbal description, odds ratio (OR) 4.8 (95% confidence interval [CI] 2.1-10.9). Subjects with low or marginal health literacy were also more likely than subjects with adequate health literacy to have preferences for aggressive care after the verbal description, OR 17.3 (95% CI 6.0-49.9) and OR 11.3 (95% CI 4.2-30.8) respectively. In adjusted analyses, health literacy (low health literacy: OR 7.1, 95% CI 2.1-24.2; marginal health literacy OR 5.1, 95% CI 1.6-16.3) but not race (OR 1.1, 95% CI 0.3-3.2) was an independent predictor of preferences after the verbal description. After watching a video of advanced dementia, there were no significant differences in the distribution of preferences by race or health literacy. CONCLUSIONS: Health literacy and not race was an independent predictor of end-of-life preferences after hearing a verbal description of advanced dementia. In addition, after viewing a video of a patient with advanced dementia there were no longer any differences in the distribution of preferences according to race and health literacy. These findings suggest that clinical practice and research relating to end-of-life preferences may need to focus on a patient education model incorporating the use of decision aids such as video to ensure informed decision-making.

Brian MacMahon (1923-2007): founder of modern epidemiology.

Brian MacMahon was born in Sheffield, UK in 1923. He served as chair of the Department of Epidemiology at Harvard School of Public Health for more than 30 years. He was admired as a noble and generous man and respected for his shining intellect, scientific integrity, and broad culture. He set the pace for modern epidemiology and led the way for a whole school of epidemiologists who are now spread around the nation and the world. He made major scientific contributions, received several distinguished prizes and awards, and continued to publish insightful papers until the very end. Brian MacMahon was the first editor-in-chief of Cancer Causes and Control.

A prospective comparative study of five measures of gluten-free diet adherence in adults with coeliac disease.

BACKGROUND: Increasing numbers of individuals are now being diagnosed with coeliac disease. The only accepted treatment for coeliac disease is lifelong adherence to a strict gluten-free diet (GFD). Individuals' ability to adhere to the GFD varies, but systematic studies guiding the assessment of adherence are currently lacking. AIM: We sought to compare the predictive value of self-report and four serologic tests compared to expert nutritionist evaluation. METHODS: In all, 154 individual adults with biopsy-proven coeliac disease rated their adherence to the GFD on a Likert scale. Serum antibody titres of IgA anti-tissue transglutaminase, and IgA and IgG anti-deamidated gliadin peptides were determined. Using anova and ROC analyses, results were compared to a standardized evaluation by an expert nutritionist blinded to the participants' self-rated adherence and serology results. RESULTS: All serologic measures as well as participant reported adherence were significantly associated with GFD adherence as assessed by expert nutritionist evaluation. However, on ROC analysis no measure performed satisfactorily. The performance of serologic testing, but not self-report, improved with increased time on the GFD. CONCLUSION: Although current serologic tests have very high sensitivities and specificities for the diagnosis of coeliac disease, they cannot replace trained nutritionist evaluation in the assessment of GFD adherence.

Patterns of practice and outcomes in intermediate- and high-risk stage I and II endometrial cancer: a population-based study.

To evaluate patterns of practice and outcomes in intermediate- and high-risk stage I and II endometrial cancer in the province of Ontario, Canada. This was a retrospective population-based study of women diagnosed with stage I and II endometrial cancer in Ontario from 1996 to 2000. After excluding low-risk (stages IA and IB, grades 1 and 2) and nonendometrioid histologies, the population was stratified into two risk groups: intermediate risk (stages IA and IB, grade 3; stages IC and IIA, grades 1 and 2; stage IIA, grade 3 if <50% myometrial invasion) and high risk (stage IC, grade 3; stage IIA, grade 3 if >50% myometrial invasion, and all stage IIB). Patterns of practice were assessed in each risk group, including use of surgical staging and adjuvant pelvic radiotherapy (APRT). Cox proportional hazards models determined effects of prognostic factors on 5-year overall survival (OS), including age, income, comorbidities, lymphvascular space invasion (LVSI), surgical staging, and APRT. There were 995 women in this study: 748 intermediate risk (75.2%) and 247 high risk (24.8%). Only 69 (9.2%) and 40 (16.2%) women underwent surgical staging in the intermediate- and high-risk groups, respectively. Surgical staging did not reduce rates of APRT. Determinants of survival included age >60 and comorbidities in the intermediate-risk group, and age >60, income, and LVSI in the high-risk group. In this population-based study, there were variable patterns of practice for intermediate- and high-risk stage I and II endometrial cancer. Surgical staging and APRT did not affect OS.

Accuracy of ICD-9 coding for Clostridium difficile infections: a retrospective cohort.

Clostridium difficile (C. diff) is a major nosocomial problem. Epidemiological surveillance of the disease can be accomplished by microbiological or administrative data. Microbiological tracking is problematic since it does not always translate into clinical disease, and it is not always available. Tracking by administrative data is attractive, but ICD-9 code accuracy for C. diff is unknown. By using a large administrative database of hospitalized patients with C. diff (by ICD-9 code or cytotoxic assay), this study found that the sensitivity, specificity, positive, and negative predictive values of ICD-9 coding were 71%, 99%, 87%, and 96% respectively (using micro data as the gold standard). When only using symptomatic patients the sensitivity increased to 82% and when only using symptomatic patients whose test results were available at discharge, the sensitivity increased to 88%. C. diff ICD-9 codes closely approximate true C. diff infection, especially in symptomatic patients whose test results are available at the time of discharge, and can therefore be used as a reasonable alternative to microbiological data for tracking purposes.

Risk stratification for in-hospital mortality in spontaneous intracerebral haemorrhage: a Classification and Regression Tree analysis.

BACKGROUND: Risk stratification for mortality in intracerebral haemorrhage (ICH) helps guide care, but existing clinical prediction rules are too cumbersome for clinical practice because of their complexity. AIM: To develop a simple decision tree model of in-hospital mortality risk stratification for ICH patients. METHODS: We collected information on spontaneous ICH patients hospitalized in a teaching hospital in Japan from August, 1998 to December, 2001 (n = 374). All variables were abstracted from data available at the time of initial evaluation. A prediction rule for in-hospital mortality was developed by the Classification and Regression Tree (CART) methodology. The accuracy of the model was evaluated using the area under receiver-operator characteristic curve. RESULTS: Overall in-hospital mortality rate was 20.2%. The CART methodology identified four groups for mortality risk, varying from low (2.1%) to high (58.9%). Level of consciousness (coma) was the best single predictor for mortality, followed by high ICH volume (cut-off 10.4 ml), and then age (cut-off 75 years). The accuracy of our CART model (0.86) exceeded that of a multivariate logistic regression model (0.81). DISCUSSION: ICH patients can easily be stratified for mortality risk, based on three predictors available on admission. This simple decision tree model provides clinicians with a reliable and practical tool.

Identification of chlamydia and gonorrhoea among women in rural Haiti: maximising access to treatment in a resource poor setting.

OBJECTIVE: To develop a risk assessment algorithm that will increase the identification and treatment of women with cervical infection in rural Haiti. METHODS: Study participants were randomly selected from new patients who accessed services at a women's health clinic in rural Haiti between June 1999 and December 2002. This case-control study included women who tested positive for chlamydia and/or gonorrhoea based on the Gen-Probe PACE 2 laboratory test as cases. Controls were women who tested negative for both of these infections. RESULTS: Women from this area of rural Haiti had a limited level of education and lived in impoverished housing conditions. The sensitivity estimates of Haitian Ministry of Health and WHO algorithms for detecting chlamydia and/or gonorrhoea were generally low (ranging from 16.1% to 68.1%) in this population. Risk scores based on logistic regression models of local risk factors for chlamydia and gonorrhoea were developed and sensitivity estimates were higher for algorithms based on these risk scores (up to 98.8%); however, specificity was compromised. CONCLUSIONS: A risk assessment algorithm to identify women with chlamydia and/or gonorrhoea is more sensitive and less specific than the syndromic management approach advocated by WHO and adapted by the Haitian Ministry of Health. Using a risk assessment tool with high sensitivity based on local risk factors of cervical infection will maximise access to care, improve outcomes, and decrease morbidity in women who have cervical infection in rural Haiti.

Quality of informed consent in cancer clinical trials: a cross-sectional survey.

BACKGROUND: Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconceptions in participants and providers. METHODS: We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated institutions, and surveyed the provider who obtained each patient's consent. FINDINGS: 207 of 287 (72%) patients responded. 90% (186) of these respondents were satisfied with the informed consent process and most considered themselves to be well informed. Nevertheless, many did not recognise non-standard treatment (74%), the potential for incremental risk from participation (63%), the unproven nature of the treatment (70%), the uncertainty of benefits to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with college education, speaking only English at home, use of the US National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients. INTERPRETATION: Misconceptions about cancer clinical trials are frequent among trial participants, and physician/investigators might share some of these misconceptions. Efforts to educate providers and participants about the underlying goals of clinical trials are needed.

Intention to discontinue care among primary care patients: influence of physician behavior and process of care.

BACKGROUND: Specific elements of health care process and physician behavior have been shown to influence disenrollment decisions in HMOs, but not in outpatient settings caring for patients with diverse types of insurance coverage. OBJECTIVE: To examine whether physician behavior and process of care affect patients' intention to return to their usual health care practice. DESIGN: Cross-sectional patient survey and medical record review. SETTING: Eleven academically affiliated primary care medicine practices in the Boston area. PATIENTS: 2,782 patients with at least one visit in the preceding year. MEASUREMENT: Unwillingness to return to the usual health care practice. RESULTS: Of the 2,782 patients interviewed, 160 (5.8%) indicated they would not be willing to return. Two variables correlated significantly with unwillingness to return after adjustment for demographics, health status, health care utilization, satisfaction with physician's technical skill, site of care, and clustering of patients by provider: dissatisfaction with visit duration (odds ratio [OR], 3.2; 95% confidence interval [CI], 1.4 to 7.4) and patient reports that the physician did not listen to what the patient had to say (OR, 8.8; 95% CI, 2.5 to 30.7). In subgroup analysis, patients who were prescribed medications at their last visit but who did not receive an explanation of the purpose of the medication were more likely to be unwilling to return (OR, 4.9; 95% CI, 1.8 to 13.3). CONCLUSION: Failure of physicians to acknowledge patient concerns, provide explanations of care, and spend sufficient time with patients may contribute to patients' decisions to discontinue care at their usual site of care.

Right heart catheterization and cardiac complications in patients undergoing noncardiac surgery: an observational study.

CONTEXT: Right heart catheterization (RHC) is commonly performed before high-risk noncardiac surgery, but the benefit of this strategy remains unproven. OBJECTIVE: To evaluate the relationship between use of perioperative RHC and postoperative cardiac complication rates in patients undergoing major noncardiac surgery. DESIGN: Prospective, observational cohort study. SETTING: Tertiary care teaching hospital in the United States. PATIENTS: Patients (n = 4059 aged >/=50 years) who underwent major elective noncardiac procedures with an expected length of stay of 2 or more days between July 18, 1989, and February 28, 1994. Two hundred twenty one patients had RHC and 3838 did not. MAIN OUTCOME MEASURE: Combined end point of major postoperative cardiac events, including myocardial infarction, unstable angina, cardiogenic pulmonary edema, ventricular fibrillation, documented ventricular tachycardia or primary cardiac arrest, and sustained complete heart block, classified by a reviewer blinded to preoperative data. RESULTS: Major cardiac events occurred in 171 patients (4.2%). Patients who underwent perioperative RHC had a 3-fold increase in incidence of major postoperative cardiac events (34 [15.4%] vs 137 [3.6%]; P<.001). In multivariate analyses, the adjusted odds ratios (ORs) for postoperative major cardiac and noncardiac events in patients undergoing RHC were 2.0 (95% confidence interval [CI], 1.3-3.2) and 2.1 (95% CI, 1.2-3.5), respectively. In a case-control analysis of a subset of 215 matched pairs of patients who did and did not undergo RHC, adjusted for propensity of RHC and type of procedure, patients who underwent perioperative RHC also had increased risk of postoperative congestive heart failure (OR, 2.9; 95% CI, 1.4-6.2) and major noncardiac events (OR, 2.2; 95% CI, 1.4-4.9). CONCLUSIONS: No evidence was found of reduction in complication rates associated with use of perioperative RHC in this population. Because of the morbidity and the high costs associated with RHC, the impact of this intervention in perioperative care should be evaluated in randomized trials.

Usefulness of transthoracic echocardiography as a tool for risk stratification of patients undergoing major noncardiac surgery.

Transthoracic echocardiography (TTE) is frequently ordered before noncardiac surgery, although its ability to predict perioperative cardiac complications is uncertain. To evaluate the incremental information provided by TTE after consideration of clinical data for prediction of cardiac complications after noncardiac surgery, 570 patients who underwent TTE before major noncardiac surgery at a university hospital were studied. Preoperative clinical data and clinical outcomes were collected prospectively according to a structured protocol. TTE data included left ventricular (LV) function, hypertrophy indexes, and Doppler-derived measurements. In univariate analyses, preoperative systolic dysfunction was associated with postoperative myocardial infarction (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.1 to 7.0), cardiogenic pulmonary edema (OR 3.2, 95% CI 1.4 to 7.0), and major cardiac complications (OR 2.4, 95% Cl 1.3 to 4.5). Moderate to severe LV hypertrophy, moderate to severe mitral regurgitation, and increased aortic valve gradient were also associated with major cardiac events (OR 2.3, 95% CI 1.2 to 4.6; OR 2.2, 95% CI 1.1 to 4.3; OR 2.1, 95% CI 1.0 to 4.5, respectively). In logistic regression analysis, models with echocardiographic variables predicted major cardiac complications significantly better than those that included only clinical variables (c statistic 0.73 vs 0.68; p <0.05). Echocardiographic data added significant information for patients at increased risk for cardiac complications by clinical criteria, but not in otherwise low-risk patients. In conclusion, preoperative TTE before noncardiac surgery can provide independent information about the risk of postoperative cardiac complications in selected patients.

Critical pathways intervention to reduce length of hospital stay.

PURPOSE: Despite their popularity, critical pathways have been evaluated in only a few controlled studies. We evaluated the effectiveness of critical pathways in reducing length of hospital stay. SUBJECTS AND METHODS: We compared postoperative lengths of stay of patients who underwent coronary artery bypass graft (CABG) surgery, total knee replacement, colectomy, thoracic surgery, or hysterectomy before and after pathway implementation at a university hospital. For three procedures, changes in lengths of stay at neighboring hospitals without pathway programs were assessed for comparison. RESULTS: A total of 6,796 patients underwent one of the procedures during the study. The percentage of eligible patients managed on a critical pathway ranged from 94% for hysterectomy to 26% for colectomy. For most procedures, the postoperative length of stay was decreasing during the baseline period. After pathway implementation, the length of stay decreased 21% for total knee replacement, 9% for CABG surgery, 7% for thoracic surgery, 5% for hysterectomy, and 3% for colectomy (all P < 0.01). However, similar decreases were seen in the neighboring hospitals that did not have critical pathways or other specific efficiency initiatives. CONCLUSIONS: Critical pathways were associated with a rapid reduction in postoperative length of stay after all five study procedures. Secular trends at nearby hospitals, however, produced comparable reductions for the three procedures available for comparison. These findings raise questions about the effectiveness of critical pathways in a competitive environment.

Influence of financial productivity incentives on the use of preventive care.

PURPOSE: We examined whether physician factors, particularly financial productivity incentives, affect the provision of preventive care. SUBJECTS AND METHODS: We surveyed and reviewed the charts of 4,473 patients who saw 1 of 169 internists from 11 academically affiliated primary care practices in Boston. We abstracted cancer risk factors, comorbid conditions, and the dates of the last Papanicolaou (Pap) smear, mammogram, cholesterol screening, and influenza vaccination. We obtained physician information including the method of financial compensation through a mailed physician survey. We used multivariable logistic regression to examine the association between physician factors and four outcomes based on Health Plan Employer Data and Information Set (HEDIS) measures: (1) Pap smear within the prior 3 years among women 20 to 75 years old; (2) mammogram in the prior 2 years among women 52 to 69 years old; (3) cholesterol screening within the prior 5 years among patients 40 to 64 years old; and (4) influenza vaccination among patients 65 years old and older. All analyses accounted for clus-tering by provider and site and were converted into adjusted rates. RESULTS: After adjustment for practice site, clinical, and physician factors, patients cared for by physicians with financial productivity incentives were significantly less likely than those cared for by physicians without this incentive to receive Pap smears (rate difference, 12%; 95% confidence interval [CI]: 5% to 18%) and cholesterol screening (rate difference, 4%; 95% CI: 0% to 8%). Financial incentives were not significantly associated with rates of mammography (rate difference, -3%; 95% CI: -15% to 10%) or influenza vaccination (rate difference, -13%; 95% CI: -28% to 2%). CONCLUSIONS: Our findings suggest that some financial productivity incentives may discourage the performance of certain forms of preventive care, specifically Pap smears and cholesterol screening. More studies are needed to examine the effects of financial incentives on the quality of care, and to examine whether quality improvement interventions or incentives based on quality improve the performance of preventive care.

Quality of informed consent: a new measure of understanding among research subjects.

BACKGROUND: The informed consent of participants is ethically and legally required for most research involving human subjects. However, standardized methods for assessing the adequacy of informed consent to research are lacking. METHODS AND RESULTS: We designed a brief questionnaire, the Quality of Informed Consent (QuIC), to measure subjects' actual (objective) and perceived (subjective) understanding of cancer clinical trials. The QuIC incorporates the basic elements of informed consent specified in federal regulations, assesses the therapeutic misconception (the belief that all aspects of a clinical trial are designed to directly benefit the subject), and employs the language and structure of the new National Cancer Institute template for informed consent documents. We modified the QuIC after receiving feedback from pilot tests with cancer research subjects, as well as validation from two independent expert panels. We then sent the QuIC to 287 adult cancer patients enrolled on phase I, II, or III clinical trials. Two hundred seven subjects (72%) completed the QuIC. To assess test-retest reliability, a random sample of 32 respondents was selected, of whom 17 (53%) completed the questionnaire a second time. The test-retest reliability was good with intraclass correlation coefficients of.66 for tests of objective understanding and.77 for tests of subjective understanding. The current version of the QuIC, which consists of 20 questions for objective understanding and 14 questions for subjective understanding, was tested for time and ease of administration in a sample of nine adult cancer patients. The QuIC required an average of 7.2 minutes to complete. CONCLUSIONS: The QuIC is a brief, reliable, and valid questionnaire that holds promise as a standardized way to assess the outcome of the informed consent process in cancer clinical trials.

Obstacles to collaborative quality improvement: the case of ambulatory general medical care.

OBJECTIVE: To assess the effectiveness of inter-site collaboration and report-card style feedback of quality measures on quality improvement in the outpatient setting and to identify major barriers to improvement. DESIGN: A collaborative quality improvement effort consisting of a large cross-sectional data collection effort (chart reviews and patient surveys), feedback of comparative quality of care data to improvement teams, and collaboration between sites. SETTING: Eleven primary care sites in the Boston area. STUDY PARTICIPANTS: Quality improvement teams at each site with physician leaders. INTERVENTION: Education about techniques of rapid-cycle quality improvement, coaching of on-site teams, and report-card style feedback of comparative site-specific quality of care data. RESULTS: Multiple quality improvement projects were undertaken through this collaboration. However, though we were careful to educate teams on methods of continuous quality improvement and to name specific clinical leaders, the degree of collaboration and quality improvement fell short of expectations. Major impediments to improvement included lack of team members' time and resources, lack of incentives, and unempowered team leadership. The primary obstacle to collaboration was the diversity of sites and inability of teams to create interventions that were relevant to other sites. CONCLUSION: Despite ample quality of care data, quality improvement education, and a structured collaborative process, achieving quality improvement in the ambulatory setting is still a difficult challenge. Organizations need to find ways of overcoming the obstacles faced by improvement teams in order to maximize quality improvement.