Words of wisdom: re: survival associated with treatment vs observation of localized prostate cancer in elderly men. Wong Y, Mitra N, Hudes G, et al. JAMA 2006;296:2683-93.
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Comment↗
Biomedical subjects
Michael J Barry
Publications and source records attributed to Michael J Barry.
The rising prevalence of androgen deprivation among older American men since the advent of prostate-specific antigen testing: a population-based cohort study.
OBJECTIVE: To investigate the effect of efforts in the early detection of prostate cancer using prostate-specific antigen (PSA) testing in the USA, by estimating the regional prevalence of androgen deprivation therapy (ADT) among older men in 1993-2000, and correlating the prevalence with early detection and aggressive treatment rates in 1987-91, as some authors predicted that ADT, a treatment traditionally reserved for advanced prostate cancer, would become less common over time as a result of such efforts. PATIENTS AND METHODS: A sample of 5% of men who were Medicare beneficiaries was used in this prospective population-based cohort study. The main outcome measures were the overall prevalence of ADT (medical and surgical) in the cohort from 1993 to 2000, and correlations between rates of prostate procedures in the 306 USA hospital referral regions in 1987-91 and prevalence of ADT in those regions from 1993 to 2000. RESULTS: The prevalence of ADT among these men in the USA increased steadily from 1.8% in 1993 to 2.9% in 2000 (P < 0.001). Regions with higher rates of prostate biopsy in 1987-91 had a higher prevalence of ADT in 1993, 1995 and 1997 (P < 0.05). Regions with higher rates of transurethral prostatectomy in 1987-91 had a higher prevalence of ADT in 1993-2000 (P < 0.01). Regions with higher rates of radical prostatectomy in 1987-91 had higher rates of ADT in 1993-99 (P < 0.05). CONCLUSIONS: Widespread early detection and aggressive treatment for prostate cancer in the USA has been associated with more, not less, ADT among older men over time.
Aged↗
The PSA Conundrum.
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Case-Control Studies↗
Health outcomes in older men with localized prostate cancer: results from the Prostate Cancer Outcomes Study.
PURPOSE: We compared health-related quality-of-life (HRQOL) outcomes and survival of men with localized prostate cancer who received aggressive treatment with those receiving conservative management. METHODS: We conducted a population-based cohort study of men aged 75 to 84 years when diagnosed with a clinically localized cancer in 1994 or 1995. We used medical record abstractions and patient surveys to obtain clinical and HRQOL data at diagnosis and 24-month follow-up. We used a propensity score method to adjust for baseline differences between men treated with radical prostatectomy or radiation therapy (n = 175) and men who received hormone therapy or no treatment (n = 290). Propensity scores were used in regression analyses comparing HRQOL outcomes between treatment groups. Overall and disease-specific survivals were estimated with multivariate proportional hazards models. RESULTS: At 24 months following diagnosis, aggressively treated men were more likely to report daily urinary leakage (odds ratio [OR] = 2.9, 95% confidence interval [CI] 1.2-7.0) and to be bothered by urinary problems (OR = 5.1, 95% CI, 1.3-9.1) and sexual problems (OR = 2.8, 95% CI, 1.2-6.3). The adjusted disease-specific mortality hazard ratio was 0.43 (95% CI, 0.15, 1.28), favoring aggressive treatment. However, the absolute 5-year disease-specific survival difference was only 6% (98% vs 92%). Over 80% of all deaths were from other causes. CONCLUSIONS: Aggressive treatment was associated with significant decreases in disease-specific HRQOL. However, men who were aggressively treated for localized cancer had a minimally reduced absolute risk of dying from prostate cancer. Physicians and older patients should consider these outcomes in making decisions about screening and treatment.
Age Factors↗
Prostate cancer prevention and finasteride.
PURPOSE: We assessed whether the association between the larger changes in prostate specific antigen and high grade prostate cancer observed in the Prostate Cancer Prevention Trial can explain the increased detection of high grade prostate cancer in men randomized to finasteride vs placebo. MATERIALS AND METHODS: A literature review was performed to obtain evidence to develop a hypothesis that may explain the results of the Prostate Cancer Prevention Trial. RESULTS: On average finasteride halved prostate specific antigen. As shown by the Medical Therapy of Prostatic Symptoms study and Prostate Cancer Prevention Trial, it also decreased the annual median increase in prostate specific antigen from benign prostatic hyperplasia. Therefore, despite doubling prostate specific antigen during the first 3 years of the Prostate Cancer Prevention Trial, to have prostate specific antigen exceed 4 ng/ml and have a prostate biopsy recommended men receiving finasteride vs placebo required greater increases in prostate specific antigen, which was shown in the Prostate Cancer Prevention Trial to be associated with high grade disease (p < 0.001). Also, the decrease of the contribution to prostate specific antigen from benign prostatic hyperplasia by finasteride improved the performance characteristics of prostate specific antigen to detect Gleason score 7 or higher prostate cancer. CONCLUSIONS: By decreasing the contribution to prostate specific antigen from benign prostatic hyperplasia finasteride makes changes in prostate specific antigen more cancer specific. This effect may explain the increased detection of high grade prostate cancer in men randomized to finasteride in the Prostate Cancer Prevention Trial. How to best use prostate specific antigen to recommend biopsy in men on 5alpha-reductase inhibitors requires further study.
Enzyme Inhibitors↗
Brief report: physicians and their personal prostate cancer-screening practices with prostate-specific antigen. A national survey.
BACKGROUND: There is inconclusive evidence that prostate cancer screening with prostate-specific antigen (PSA) reduces mortality. Although PSA testing is widespread, it is unknown how many physicians have taken the PSA test themselves. OBJECTIVE: To determine the prevalence of PSA testing among physicians. DESIGN: Cross-sectional survey. SUBJECTS: A nationwide stratified random sample of urologists (response rate 61%, n=247), Internists (response rate 51%, n=273), and family physicians (response rate 64%, n=249) were surveyed by mail in 2000. After excluding female respondents and men who either reported a positive history of prostate cancer or did not respond to that query, there were 146 urologists, 96 Internists, and 118 family physicians. MEASUREMENTS: Whether physicians had undergone prostate cancer screening with PSA. RESULTS: Eighty-seven percent (155/178) of male physicians aged, 50 and older and 21% (31/150) of white male physicians under age 50 reported having had a PSA test. More urologists than nonurologists in both age groups reported having had a screening PSA test. CONCLUSION: Most physicians aged 50 and older report undergoing PSA testing. This may reflect a belief in its efficacy and contribute to its widespread use.
Confidence Intervals↗
The impact of a suspicious prostate biopsy on patients' psychological, socio-behavioral, and medical care outcomes.
OBJECTIVE: To evaluate the psychological, socio-behavioral, and medical implications of apparently false-positive prostate cancer screening results. METHODS: One hundred and twenty-one men with a benign prostate biopsy performed in response to a suspicious screening test (biopsy group) and 164 men with a normal prostate-specific antigen (PSA) test result (normal PSA group) responded to a questionnaire 6 weeks, 6 and 12 months after their biopsy or PSA test. RESULTS: The mean (+/-SD) age of respondents was 61+/-9 years (range, 41 to 88 years). One year later, 26% (32/121) of men in the biopsy group reported having worried "a lot" or "some of the time" that they may develop prostate cancer, compared with 6% (10/164) in the normal PSA group (P<.001). Forty-six percent of the biopsy group reported thinking their wife or significant other was concerned about prostate cancer, versus 14% in the normal PSA group (P<.001). Medical record review showed that biopsied men were more likely than those in the normal PSA group to have had at least 1 follow-up PSA test over the year (73% vs 42%, P<.001), more likely to have had another biopsy (15% vs 1%, P<.001), and more likely to have visited a urologist (71% vs 13%, P<.001). CONCLUSION: One year later, men who underwent prostate biopsy more often reported worrying about prostate cancer. In addition, there were related psychological, socio-behavioral, and medical care implications. These hidden tolls associated with screening should be considered in the discussion about the benefits and risks of prostate cancer screening.
Adult↗
Is this "my" patient? Development and validation of a predictive model to link patients to primary care providers.
BACKGROUND: Evaluating the quality of care provided by individual primary care physicians (PCPs) may be limited by failing to know which patients the PCP feels personally responsible for. OBJECTIVE: To develop and validate a model for linking patients to specific PCPs. DESIGN: Retrospective convenience sample. PARTICIPANTS: Eighteen PCPs from 10 practice sites within an academic adult primary care network. MEASUREMENTS: Each PCP reviewed the records for all outpatients seen over the preceding 3 years (16,435 patients reviewed) and designated each patient as "My Patient" or "Not My Patient." Using this reference standard, we developed an algorithm with logistic regression modeling to predict "My Patient" using development and validation subsets drawn from the same patient set. Quality of care was then assessed by "My Patient" or "Not My Patient" designation by analyzing cancer screening test rates. RESULTS: Overall, PCPs designated 11,226 patients (68.3%, range per provider 15% to 93%) to be "My Patient." The model accurately categorized patients in development and validation subsets (combined sensitivity 80.4%, specificity 93.7%, and positive predictive value 96.5%). To achieve positive predictive values of > 90% for individual PCPs, the model excluded 19.6% of PCP "My Patients" (range 5.5% to 75.3%). Cancer screening rates were higher among model-predicted "My Patients." CONCLUSIONS: Nearly one-third of patients seen were considered "Not My Patient" by the PCP, although this proportion varied widely. We developed and validated a simple model to link specific patients and PCPs. Such efforts may help effectively target interventions to improve primary care quality.
Adult↗
Automated identification of a physician's primary patients.
OBJECTIVE: To develop and validate an automated method for determining the set of patients for whom a given primary care physician holds overall clinical responsibility. DESIGN: The study included all adult patients (16,185) seen at least once in an ambulatory setting during a three-year period by 18 primary care physicians in ten practices. The physicians indicated whether they considered themselves to be the physician primarily responsible for the overall clinical care of each visiting patient. Statistical models were constructed to predict the physicians' designations using predictor variables derived from electronically available appointment schedules and demographic information. MEASUREMENTS: Predictive accuracy was assessed primarily using the area under the receiver-operating characteristic curve (AUC), and secondarily using positive predictive value (PPV) and sensitivity. RESULTS: A minimal set of six variables was identified as predictive of the physicians' designations. The constructed model had a median AUC for individual physicians of 0.92 (interquartile interval: 0.90-0.96), a PPV of 0.94 (interquartile interval: 0.87-0.95), and a sensitivity of 0.95 (interquartile interval: 0.87-0.97). CONCLUSION: A statistical model using a minimal set of commonly available electronic data can accurately predict the set of patients for whom a physician holds primary clinical responsibility. Further research examining the generalization of the model to other settings would be valuable.
Adult↗
Managing patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Many men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia can be managed safely and effectively by primary care providers. After a basic evaluation to exclude other diseases that may cause lower urinary tract symptoms, quantifying the degree of symptoms and bother, and perhaps making an assessment of prostate size, the primary care provider can determine which men require immediate evaluation by a urologist and which men may choose among various treatment options, including watchful waiting and various single agent or combination medication strategies. Recent information about risk factors for disease progression has also helped to inform patient decisions on which treatment option is best for the individual patient. The purpose of this review is to provide primary care providers with an approach to the management of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Adrenergic alpha-Antagonists↗
Revisiting my personal decision about prostate-specific antigen testing in 2005.
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Biomarkers, Tumor↗
The role of point of care testing for patients with acute pharyngitis.
BACKGROUND: There is no consensus favoring a particular strategy for evaluating patients with pharyngitis. OBJECTIVE: To compare a clinical decision aid and a rapid office-based point of care (POC) test with routine culture for group A beta-hemolytic streptococcus (GAS). DESIGN: Prospective observational study. PARTICIPANTS: Among 179 patients enrolled, 150 were eligible and 148 had POC testing and cultures initially performed. MEASUREMENTS: An encounter form included eligibility criteria, clinical information based upon the Centor rule, and treatment provided. Sensitivity and specificity of POC test compared to routine culture for GAS. RESULTS: Thirty-eight patients (25.7%) had a positive GAS culture. The POC test was 92.1% sensitive (95% confidence interval [CI] 80% to 98%) and 100% specific (95% CI 97% to 100%). Although the Centor rule did not adequately discriminate among symptomatic patients with or without GAS (receiver operating curve area 0.63), the 3 patients with a false-negative POC test had a Centor score of less than 2. Among patients with a negative POC test, 26% initially received antibiotics. CONCLUSIONS: For patients with a Centor score of > or =2, a POC test was highly sensitive for GAS. Future studies should confirm these results and assess whether implementation of POC testing as part of a local practice guideline can decrease variability in testing and treatment.
Acute Disease↗
Psychological effects of a suspicious prostate cancer screening test followed by a benign biopsy result.
PURPOSE: To evaluate the psychological implications of an apparently false-positive screening result for prostate cancer. METHODS: The sample comprised 167 men with a benign biopsy result in response to a suspicious screening test result (biopsy group) and 233 men with a normal prostate-specific antigen (PSA) test result (control group). The men responded to a questionnaire within about 6 weeks of their biopsy or PSA results. They were asked about demographic characteristics, medical history, psychological effects, biopsy experience, and prostate cancer knowledge. RESULTS: The survey response rate was 85% (400/471). The mean (+/- SD) age of respondents was 60 +/- 9 years (range, 40 to 88 years); 88% (n = 350) were white. Forty-nine percent (81/167) of men in the biopsy group reported having thought about prostate cancer either "a lot" or "some of the time", compared with 18% (42/230) in the control group (P < 0.001). In addition, 40% (67/167) in the biopsy group reported having worried "a lot" or "some of the time" that they may develop prostate cancer, compared with 8% (18/231) in the control group (P < 0.001). CONCLUSION: Men who underwent prostate biopsy more often reported having thought and worried about prostate cancer, despite having received a benign result. This underrecognized human cost of screening should be considered in the debate about the benefits and harms of prostate cancer screening.
Adult↗
Effects of invertebrate predators and a pesticide on temporary pond microcosms used for aquatic toxicity testing.
The effects of increased trophic complexity, through the addition of predatory notonectids (Anisops deanei), on temporary pond microcosms used for aquatic toxicity testing were studied. Replicate microcosms were established using sediment from a dried temporary pond, and treated with one of four concentrations of the organochlorine pesticide endosulfan (0, 1, 10 or 50 microg/L), in the presence or absence of six A. deanei. The tanks were sampled regularly for nine weeks following the addition of the predators and the entire contents of each tank counted after 12 weeks. Analysis using non-metric multidimensional scaling (MDS) and non-parametric MANOVA showed that both Anisops and endosulfan at concentrations >10 microg/L significantly altered community structure. However, an interaction between the effects of Anisops and the effects of endosulfan was not detected. The addition of Anisops did not increase the variability of response and thus did not reduce the sensitivity of the test method.
Animals↗
Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000.
Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints, such as tumor shrinkage or patient compliance, to final endpoints, such as survival or disease-free survival. Three types of nontraditional endpoints that are of growing interest-health-related quality of life (QOL), satisfaction with care, and economic cost impact-hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment. In this article we review the last decade's published literature regarding the health-related QOL, satisfaction, and economic outcomes of prostate cancer screening and treatment to determine the "state of the science" of outcomes measurement. The focus is the enumeration of the types of outcome measurement used in the studies not the determination of the results of the studies. Studies were identified by searching Medline (1990-2000). Articles were included if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened and treated for prostate cancer. Review papers were excluded unless they were quantitative syntheses of the results of other primary studies. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts. Each retrieved article was reviewed by one of the authors. Included papers were assigned one primary, mutually exclusive study design. For the "primary data" studies, information was abstracted on care setting, dates of the study, sample size, racial distribution, age, tumor differentiation, tumor stage, survival, statistical power, and types of outcomes measures (QOL-generic, QOL-cancer specific, QOL-prostate cancer specific, satisfaction, costs, utilities, and other). For the "economic and decision analytic" papers, information was abstracted on stage of disease, age range, outcomes, costs, and whether utilities were measured. Of the 198 included papers, there were 161 primary data papers categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The remaining 37 papers were economic and decision analytic papers. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard); three papers included seven outcomes measures, and one paper included nine. Over the 11-year time period, there was a nonstatistically significant trend toward more frequent use of standardized QOL instruments and a statistically significant trend toward increased reporting of race (P = .003). Standardization of measurement of health-related QOL, satisfaction with care, and economic cost effect among men screened and treated for prostate cancer is needed. A core set of similar questions, both generic and disease-specific, should ideally be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how patients screened and treated for this condition are doing over time.
Health Care Costs↗
Validity of primary care patient self-report of abnormal (but not cancer) prostate biopsy results.
PURPOSE: We assessed the validity of patient self-report of abnormal (but not cancer) prostate biopsy results, ie, atypical cells or prostatic intraepithelial neoplasia. MATERIALS AND METHODS: We compared survey responses and pathology records for 156 men from a multicenter, prospective cohort study, which was designed to evaluate the impact of a suspicious prostate cancer screening test followed by benign prostate biopsy. RESULTS: Of the 156 subjects 45 (29%) reported having had atypical cells or prostatic intraepithelial neoplasia and 38 (24%) had a pathology report with atypia or prostate intraepithelial neoplasia. The sensitivity of the self-report was 87%, specificity was 90%, positive predictive value was 73% and negative predictive value was 95%. The kappa statistic was 0.7. CONCLUSIONS: Men in this study reported this complex result accurately. However, it was concerning that 5 men (13%) appeared unaware of an abnormal prostate biopsy result, especially given the substantial residual risk of prostate cancer conferred by this result.
Aged↗
Overcoming information overload: an information system for the primary care physician.
Primary Care Office InSite (PCOI) is a Web-based intranet application that provides ready access to a collection of information useful in primary care. The PCOI Web site was developed by, and is widely used within, the Massachusetts General Hospital (MGH) and its affiliated community practices. Over 1600 users logged 60,000 separate sessions in the past year. The site contains clinical practice guidelines, patient educational material, drug prescription and cost information and referral information, all designed for use during routine patient care activity. A continuing and dynamic collaboration between the users and developers of the system, just-in-time access and a "one-stop portal" to a variety of resources have resulted in a very high approval rating by the users. This paper discusses the important characteristics of the Web site, specific functions that improve the workflow of the practicing clinician, and limitations of the present implementation.
Ambulatory Care Information Systems↗
Challenges to the effective use of unfractionated heparin in the hospitalized management of acute thrombosis.
BACKGROUND: Unfractionated heparin therapy is care intensive because of dose-response variability, and because of the necessity of constant intravenous infusion and frequent monitoring. We sought to assess the real-world course of transition from heparin to warfarin in hospitalized patients undergoing anticoagulation therapy for acute venous or arterial thrombosis at our medical center. METHODS: Patients were retrospectively identified from July 1998 to December 1998. Data collected included initiation and maintenance doses of heparin, frequency of monitoring and dose adjustments, time to the therapeutic range, complications and interruptions of therapy, and characteristics of heparin-to-warfarin transition. RESULTS: Of the 311 patients who met the study criteria during the 6-month period, 134 had venous thromboembolism, 122 had cerebral arterial thrombosis, and 55 had peripheral arterial thrombosis. Groups differed in use and magnitude of initial heparin bolus, frequency of monitoring, and time to the therapeutic range. Dose response to intravenous heparin was highly variable. Even when the activated partial thromboplastin time reached the therapeutic range of 55 to 85 seconds, the next 2 consecutive measurements remained in this range in only 29% of the patients. Patients received an average of 4 different heparin doses over the first 3 days of treatment, and the therapeutic range was maintained on each of 4 sequential days in only 7% of them. During the course of therapy, 54% of the patients had at least 1 prolonged interruption in heparin infusion, and 4.8% sustained a major hemorrhage. Overall, 20% of the patients met the currently recommended treatment guideline of 4 days or more of heparin and warfarin overlap, until the international normalized ratio is greater than 2.0 for 2 consecutive days. CONCLUSIONS: Multiple challenges to effective anticoagulation treatment with unfractionated heparin exist in the hospital setting. Strategies are needed to improve the overall quality of anticoagulant care, including the substitution of low-molecular-weight heparin for unfractionated heparin, where appropriate.
Adolescent↗