PubMed Health⌕ Search

Biomedical subjects

Timothy J Wilt

Publications and source records attributed to Timothy J Wilt.

35 records · Page 2Linked to original sources

Measuring patient knowledge of the risks and benefits of prostate cancer screening.

This manuscript describes the development and validation of measures assessing patient knowledge about the risks and benefits of prostate cancer (CaP) screening. The measures described include a 10-item knowledge index and four single-item measures, used in previous studies, that assess knowledge of: CaP natural history and treatment efficacy, expert disagreement over the value of CaP screening, and the accuracy of the prostate specific antigen (PSA) test for CaP. We assessed the validity and reliability of these measures on a sample of 1152 male veteran patients age 50 and older. All knowledge index items had acceptable levels of discrimination, difficulty, and reliability. The index demonstrated strong evidence for construct and criterion validity. Much weaker validity evidence was found for the four single-item knowledge questions. The 10-item index developed in this study provides a valid and reliable tool for assessing patient knowledge of the risks and benefits of CaP screening.

Aged↗

Phytoestrogens for treatment of menopausal symptoms: a systematic review.

OBJECTIVE: To assess the efficacy and tolerability of phytoestrogens for treatment of menopausal symptoms. DATA SOURCES: We searched the Cochrane Library and MEDLINE from 1966 to March 2004, using a detailed list of terms related to phytoestrogens and menopausal symptoms and also hand-searched abstracts from relevant meetings. METHODS OF STUDY SELECTION: Randomized trials were eligible if they involved symptomatic perimenopausal or postmenopausal women, compared phytoestrogen with placebo or control, reported hot flush frequency or menopausal symptom scores, and were at least 4 weeks in duration. TABULATION, INTEGRATION, AND RESULTS: Data were extracted onto standardized forms using a prospectively developed protocol. Twenty-five trials involving 2,348 participants met criteria. At baseline, the mean age was 53.1 years, mean duration of menopause was 4.3 years, and mean daily hot flush frequency was 7.1. Mean study duration was 17 weeks. Trials were grouped into categories according to type of phytoestrogen: soy foods, beverages, or powders (n = 11); soy extracts (n = 9); and red clover extracts (n = 5). Of the 8 soy food trials reporting hot flush frequency outcomes, 7 were negative. Five trials of soy foods provided information to calculate effect sizes; these were in the small-to-medium range, favoring placebo in 3 trials and soy in 2. Of the 5 soy extract trials reporting hot flush frequency, 3 (including the 2 largest trials) were negative. Effect sizes were calculated for 2 soy extract trials: one favored placebo with small effect size and the other favored soy with moderate effect size. Red clover trials showed no improvement in hot flush frequency (weighted mean difference -0.60, 95% confidence interval -1.71 to 0.51). Adverse effects were primarily gastrointestinal and taste intolerance in the soy food and beverage trials. CONCLUSION: The available evidence suggests that phytoestrogens available as soy foods, soy extracts, and red clover extracts do not improve hot flushes or other menopausal symptoms.

Female↗

Transurethral microwave thermotherapy vs transurethral resection for treating benign prostatic hyperplasia: a systematic review.

OBJECTIVE: To conduct a systematic review of randomized controlled trials evaluating the efficacy and safety of transurethral microwave thermotherapy (TUMT) compared with transurethral resection of the prostate (TURP) in treating men with symptomatic benign prostatic hyperplasia (BPH). METHODS: We searched Medline, the Cochrane Library and reference lists of retrieved studies to identify randomized trials of >/= 6 months duration with >/= 10 patients in each treatment arm. Data were extracted on study design, patient and treatment characteristics, urinary symptoms, urinary flow, adverse events and repeat treatment for BPH. RESULTS: Six studies were evaluated, involving 540 patients. The mean age (67.8 years), baseline symptom score (19.5), and peak urinary flow (PUF, 8.6 mL/s) did not differ by treatment group. The pooled mean urinary symptom score decreased by 65% with TUMT and 77% with TURP. The weighted mean (95% confidence interval) difference for the symptom score at the follow-up was -1.83 (-3.09 to -0.58) points, favouring TURP. The pooled mean PUF increased by 70% with TUMT and 119% with TURP. The weighted mean difference for the PUF at the follow-up was 5.37 (4.22-6.51) mL/s, favouring TURP. Retrograde ejaculation (57.6% vs 22.2%), transfusions (5.7% vs 0%) and re-treatment for strictures (relative hazard 9.76) were all significantly more common after TURP, but re-treatment for BPH was significantly more common after TUMT (relative hazard 10.0). CONCLUSIONS: TUMT techniques are effective and safe short-term alternatives to TURP for treating BPH. However, TURP provided greater symptom and urinary flow improvements and fewer subsequent BPH treatments than TUMT.

Aged↗

Doxazosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects.

OBJECTIVE: To evaluate the efficacy and adverse effects of doxazosin for treating lower urinary tract symptoms (LUTS) compatible with benign prostatic obstruction (BPO). METHODS: Randomized controlled trials were included in the meta-analysis if: the study duration was > or = 1 month; the study involved men with symptomatic BPO; and doxazosin was compared with placebo or active controls. Study and patient characteristics and outcome data were extracted in duplicate onto standardized forms using a prospectively developed protocol. RESULTS: Thirteen studies involving 6033 men with (mean age 64 years) met the inclusion criteria; 10 were placebo-controlled, including two with combined doxazosin/finasteride therapy and finasteride monotherapy arms. Three trials were a comparison with other alpha-blockers. The study duration was 1-54 months. The mean baseline symptom scores and peak urinary flow (PUF) rates were indicative of moderate BPO. Doxazosin gave significant improvements in LUTS, assessed by symptom scores, vs placebo and finasteride in the short- to long-term. Two long-term studies (1 and 4 years) reported mean changes from baseline for the International Prostate Symptom Score of - 8.3 and - 6.6 points (-49% and - 39%) for doxazosin and - 5.7 and - 4.9 points (-33% and - 29%) for placebo, respectively. Doxazosin significantly increased PUF rates vs placebo. In pooled results from three studies, the weighted mean difference in the mean change from baseline vs placebo was 1.6 mL/s (95% confidence interval 1.2-2.1). Efficacy was comparable with other alpha1-blockers. In the long-term (>4 years) doxazosin was no better then finasteride in improving PUF. Combined doxazosin and finasteride significantly reduced the risk of overall clinical progression of BPO vs each drug separately in men followed for >4 years. Absolute risk reductions vs placebo were 11.3%, 6.9% and 6.4% for combined therapy, doxazosin and finasteride, respectively (P < 0.001). Improvements in symptom scores and PUF were also significantly greater with combined than monotherapy, and the former reduced the need for invasive treatment for BPO and the risk of long-term urinary retention, although the absolute reductions in risk vs placebo were small (<4%). Dizziness and fatigue were significantly more common with doxazosin than placebo (11% vs 7%, and 6% vs 3%, respectively). Adverse events reported for combined therapy were similar to those with each monotherapy. CONCLUSION: The evidence indicates that doxazosin is effective and generally well tolerated for improving LUTS and PUF in men with symptomatic BPO. Combined therapy was better than doxazosin alone in reducing the risk of clinical progression of BPO and other long-term complications related to BPO.

Adrenergic alpha-Antagonists↗

Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors.

OBJECTIVE: To assess the effect of video and pamphlet interventions on patient prostate cancer (CaP) screening knowledge, decision-making participation, preferences, and behaviors. DESIGN: Randomized, controlled trial. SETTING: Four midwestern Veterans Affairs medical facilities. PATIENTS/PARTICIPANTS: One thousand, one hundred fifty-two male veterans age 50 and older with primary care appointments at participating facilities were randomized and 893 completed follow-up. INTERVENTIONS: Patients were randomized to mailed pamphlet, mailed video, or usual care/control. MEASUREMENTS AND MAIN RESULTS: Outcomes assessed by phone survey 2 weeks postintervention included a 10-item knowledge index; correct responses to questions on CaP natural history, treatment efficacy, the prostate-specific antigen (PSA)'s predictive value, and expert disagreement about the PSA; whether screening was discussed with provider; screening preferences; and PSA testing rates. Mean knowledge index scores were higher for video (7.44; P = .001) and pamphlet (7.26; P = .03) subjects versus controls (6.90). Video and pamphlet subjects reported significantly higher percentages of correct responses relative to controls to questions on CaP natural history (63%, 63%, and 54%, respectively); treatment efficacy (19%, 20%, and 5%), and expert disagreement (28%, 19%, and 8%), but not PSA accuracy (28%, 22%, and 22%). Pamphlet subjects were more likely than controls to discuss screening with their provider (41% vs 32%; P = .03) but video subjects were not (35%; P = .33). Video and pamphlet subjects were less likely to intend to have a PSA, relative to controls (63%, 65%, and 74%, respectively). PSA testing rates did not differ significantly across groups. CONCLUSIONS: Mailed interventions enhance patient knowledge and self-reported participation in decision making, and alter screening preferences. The pamphlet and video interventions evaluated are comparable in effectiveness. The lower-cost pamphlet approach is an attractive option for clinics with limited resources.

Aged↗

Laser prostatectomy versus transurethral resection for treating benign prostatic obstruction: a systematic review.

PURPOSE: We conducted a systematic review of randomized controlled trials evaluating the efficacy and safety of laser prostatectomy techniques compared to transurethral resection of the prostate for symptomatic benign prostatic obstruction. MATERIALS AND METHODS: We searched MEDLINE, the Cochrane library and reference lists of retrieved studies to identify randomized trials of 6 months or greater in duration with at least 10 subjects in each treatment arm. We extracted data on study design, subject and treatment characteristics, adverse events, urinary symptoms and urinary flow. RESULTS: A total of 16 studies involving 1,488 subjects were evaluated, including 8 comparisons of transurethral resection with contact lasers, 7 with noncontact lasers and 4 with hybrid techniques. Study duration ranged from 6 to 36 months. Mean patient age (67.4 years), baseline symptom score (20.2) and peak urinary flow (9.5 ml. per second) did not differ by treatment group. Transurethral resection of the prostate provided slightly greater improvement in urinary symptoms and flow. The pooled mean percentage improvement for urinary symptoms ranged from 59% to 68% with lasers and 63% to 77% with transurethral resection. Improvement for peak urinary flow ranged from 56% to 119% with lasers and 96% to 127% with transurethral resection of the prostate. Laser procedures resulted in fewer transfusions (less than 1% versus 7%) and strictures (0% to 7% versus 8%), and required shorter hospitalizations. Reoperation occurred more often (RR = 5.7) following laser procedures. CONCLUSIONS: Laser techniques are a useful alternative to transurethral resection of the prostate for treating benign prostatic obstruction. Small sample sizes and differences in study design limit any definitive conclusions regarding the preferred type of laser technique.

Aged↗

Prostate cancer intervention. Involving the patient in early detection and treatment.

Cancer screening by PSA testing is widespread in the United States, and treatment recommendations encourage early therapy. Yet controversy about patient care persists because evidence demonstrating that these approaches improve the length and quality of a man's life is lacking. Physicians can assist their patients by first providing a balanced presentation of the known risks and benefits of prostate cancer detection and treatment and then incorporating patient preferences into medical decisions. Success in shared decision making may increase with use of patient education materials to convey most of the time-consuming and challenging information. At least two of the many materials developed can be easily administered with very few resources and independent of primary care encounters.

Aged↗

Prostate cancer: epidemiology and screening.

The 13th International Prostate Cancer Update provided an overview of diagnosis, treatment, and management strategies in prostate cancer. This article provides a summary of the reports presented during the epidemiology and screening session. Methods to improve early detection and treatment are being developed. Proposed refinements to prostate-specific antigen (PSA) testing include the use of age-specific PSA levels, PSA velocity, prostate volume-adjusted PSA densities, free-to-total PSA ratios, and complexed PSA. Optimal follow-up screening intervals for persons who elect PSA testing and are found to have initially normal levels have been proposed. Molecular oncology is becoming increasingly important in understanding the development and progression of prostate cancer as well as identifying new therapeutic targets for hormone-refractory disease. Nomograms that include PSA levels, histologic grade, and the extent of the tumor have been developed to optimize management decisions. Despite advances in early detection and treatment, controversy persists because of the lack of evidence demonstrating that they improve length and quality of life. Until results from randomized trials are completed, clinicians should provide patients with balanced information that incorporates the potential risks and benefits of screening and treatment and individual preferences for various outcomes.

Journal Article↗

Systematic review and meta-analysis of monotherapy compared with combined androgen blockade for patients with advanced prostate carcinoma.

BACKGROUND: The current systematic review and meta-analysis compared monotherapy and combined androgen blockade in the treatment of men with advanced prostate carcinoma. Outcomes of interest included overall, cancer specific, and progression-free survival; time to treatment failure; adverse events; and quality of life. METHODS: The literature search identified randomized trials comparing monotherapy (orchiectomy and luteinizing hormone-releasing hormone [LHRH] agonists) with combination therapy using orchiectomy or a LHRH agonist plus a nonsteroidal or steroidal antiandrogen. Dual independent review occurred. The meta-analysis used a random effects model. RESULTS: Twenty-one trials compared survival after monotherapy with survival after combined androgen blockade (n = 6871 patients). The meta-analysis found no statistically significant difference in survival at 2 years between patients treated with combined androgen blockade and those treated with monotherapy (20 trials; hazard ratio [HR] = 0.970; 95% confidence interval [95% CI], 0.866-1.087). The authors determined a statistically significant difference in survival at 5 years that favored combined androgen blockade (10 trials; HR = 0.871; 95% CI, 0.805-0.942). For the subgroup of patients with a good prognosis, there was no statistically significant difference in survival. Adverse effects leading to withdrawal from therapy occurred more often with combined androgen blockade. To the authors' knowledge there is little evidence published to date comparing the effects of combined androgen blockade and monotherapy on quality of life, but the single randomized trial that adequately addressed this outcome reported an advantage for monotherapy over combined androgen blockade. CONCLUSIONS: A thorough examination of the usefulness of combined androgen blockade must balance the modest increase in expected survival observed at 5 years against the increased risk of adverse effects and the potential for adversely affecting the patient's overall quality of life.

Androgen Antagonists↗

Sildenafil for male erectile dysfunction: a systematic review and meta-analysis.

OBJECTIVE: To determine the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction. DATA SOURCES: The MEDLINE, HealthSTAR, Current Contents, and Cochrane Library databases (January 1, 1995, through December 31, 2000); bibliographies of retrieved articles and review articles; conference proceedings abstracts; the Food and Drug Administration Web site; and the manufacturer. STUDY SELECTION: Trials were eligible if they included men with erectile dysfunction, compared sildenafil with control, were randomized, were of at least 7 days' duration, and assessed clinically relevant outcomes. DATA EXTRACTION: Two reviewers independently evaluated study quality and extracted data in a standardized fashion. DATA SYNTHESIS: Twenty-seven trials (6659 men) met the inclusion criteria. In results pooled from 14 parallel-group, flexible as-needed dosing trials, sildenafil was more likely than placebo to lead to successful sexual intercourse, with a higher percentage of successful intercourse attempts (57% vs 21%; weighted mean difference, 33.7; 95% confidence interval [CI], 29.2-38.2; 2283 men) and a greater percentage of men experiencing at least 1 intercourse success during treatment (83% vs 45%; relative benefit increase, 1.8; 95% CI, 1.7-1.9; 2205 men). In data pooled from 6 parallel-group, fixed-dose trials, efficacy appeared slightly greater at higher doses. Treatment response appeared to vary between patient subgroups, although relative to placebo, sildenafil significantly improved erectile function in all evaluated subgroups. In trials with parallel-group design and flexible dosing, men randomized to receive sildenafil were less likely than those receiving placebo to drop out for any reason and no more likely to drop out due to an adverse event or laboratory abnormality. Specific adverse events with sildenafil included flushing (12%), headache (11%), dyspepsia (5%), and visual disturbances (3%); all adverse events were significantly less likely to occur with placebo. Sildenafil was not significantly associated with serious cardiovascular events or death. CONCLUSIONS: Sildenafil improves erectile function and is generally well tolerated. Treatment response seems to vary between patient subgroups, although sildenafil has greater efficacy than placebo in all evaluated subgroups.

Age Factors↗

Cost-effectiveness of gemfibrozil for coronary heart disease patients with low levels of high-density lipoprotein cholesterol: the Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial.

BACKGROUND: Although numerous clinical trials and economic analyses have established the efficacy and cost-effectiveness of lowering cholesterol for the prevention of coronary heart disease, there are few data on the role of raising high-density lipoprotein cholesterol (HDL-C) levels and lowering triglyceride levels. The US Department of Veterans Affairs (VA) Cooperative Studies Program HDL-C Intervention Trial (VA-HIT) was a multicenter, randomized trial of gemfibrozil, an agent that raised HDL-C levels and lowered triglyceride levels, yet had no effect on low-density lipoprotein cholesterol (LDL-C) levels. The study showed that gemfibrozil therapy significantly reduced major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in patients with coronary heart disease, low HDL-C levels, and low LDL-C levels. OBJECTIVE: To report the results of a cost-effectiveness study based on the results of the VA-HIT. METHODS: The cost per year of life gained with gemfibrozil therapy was calculated. Hazard functions were estimated, and the resulting probabilities were used in a Markov model simulation to estimate the effect of gemfibrozil on life expectancy and costs over a simulated lifetime. Sensitivity analyses were used to account for uncertainty. RESULTS: Using the prices of gemfibrozil that were negotiated by the VA, gemfibrozil was cost saving. Using drug prices found outside the VA, a quality-adjusted life-year saved by gemfibrozil therapy cost between $6300 and $17 100. CONCLUSIONS: Gemfibrozil reduces major cardiovascular events in male coronary heart disease patients with low levels of HDL-C and low levels of LDL-C and would result in cost saving at annual drug costs of $100 or less in 1998 dollars. Even at the higher drug prices represented by the average wholesale price in the United States, the cost of a life-year saved is well below the threshold that would be deemed cost-effective. To our knowledge, this is the first economic analysis based on clinical trial data to assess the cost-effectiveness of raising HDL-C levels and lowering triglyceride levels in a setting in which LDL-C levels were not lowered.

Aged↗

Clarifying uncertainty regarding detection and treatment of early-stage prostate cancer.

Detection and treatment of prostate cancer can theoretically identify and cure a potentially disabling and deadly disease. However, controversy exists primarily because of the absence of randomized controlled trials (RCTs) documenting that these strategies improve survival and quality of life. In the absence of definitive information from RCTs, patients seek information and recommendations from many sources. Physicians have an opportunity to help patients and their families sort through the vast array of conflicting and confusing information. Rather then recommending for or against routine prostate-specific antigen (PSA) testing, physicians should provide men who are interested in prostate cancer testing, 50 years of age and older, and have a life expectancy of at least 10 to 15 years, with balanced information about the potential benefits and established harms of screening, diagnosis, and treatment. Validated informational materials can effectively and efficiently promote shared decision making. For early prostate cancer detection, the minimum information should include: the likelihood that prostate cancer will be diagnosed, possibilities of false-positive and false-negative results, anxiety associated with a positive test, and uncertainty regarding whether screening reduces the risk for death from prostate cancer. For men with localized prostate cancer, acceptable treatment options include radical prostatectomy, radiation therapy, cryotherapy, early androgen-suppression therapy, and watchful waiting. These are all considered acceptable options because data do not provide clear-cut evidence for the superiority of any 1 treatment. The only RCT comparing surgery to watchful waiting, though of relatively small size and conducted before PSA testing, showed no difference in survival after 23 years of follow-up. Watchful waiting does not remove prostate cancer, may miss an opportunity to cure or delay disease progression, and may lead to increased patient anxiety. However, watchful waiting avoids the harmful side effects of early intervention and does provide palliative therapy if and when symptomatic disease progression occurs. Furthermore, intervention is not necessary in the vast majority of men because most prostate cancers do not cause mortality or serious morbidity. Therefore, quality of life in many men treated with watchful waiting is superior to those treated with early intervention. For the minority of men with prostate cancer likely to cause disability or death, early intervention options may not be effective. Although commonly used in other countries, watchful waiting is rarely recommended in the United States. The opportunity exists to resolve the confusion, close the gaps in knowledge, and enhance prostate cancer care by conducting RCTs. Until these RCTs are completed, physicians can assist patients by providing a balanced presentation of the known risks and potential but unproven benefits of detection and treatment options and incorporating patient preferences into health care decisions.

Delivery of Health Care↗

Tamsulosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects.

PURPOSE: We systematically reviewed the effectiveness and adverse effects of tamsulosin for lower urinary tract symptoms compatible with benign prostatic obstruction. MATERIALS AND METHODS: Studies were included in analysis when they involved a randomized trial of at least 1 month in duration, men with lower urinary tract symptoms and a comparison of tamsulosin with placebo or an active control. Study, patient and outcome data were extracted onto standard forms using a prospective protocol. RESULTS: Of the series 13 involving 3,418 men with a mean age of 64 years met our inclusion criteria. Study duration was 4 to 26 weeks. Baseline symptom scores and flow rates showed moderate lower urinary tract symptoms. Tamsulosin improved symptoms and peak urine flow compared with placebo. The weighted mean difference in the mean change from baseline for the Boyarsky symptom score for 0.4 and 0.8 mg. tamsulosin versus placebo was -1.1 (95% confidence interval [CI] -1.49 to -0.72 or 12% improvement) and -1.6 points (95% CI -2.3 to -1.0 or 16% improvement), respectively. The weighted mean difference in the mean change from baseline in peak urine flow was 1.1 (95% CI 0.59 to 1.51) and 1.1 ml. per second (95% CI 0.65 to 1.48) for 0.4 and 0.8 mg., respectively. The 0.2 to 0.4 mg. tamsulosin dose was as effective as other alpha-antagonists for improving symptoms and the flow rate, although the doses of all alpha-antagonists evaluated may not have been optimal. Treatment withdrawals and adverse effects increased markedly as the tamsulosin dose increased. CONCLUSIONS: Tamsulosin improves lower urinary tract symptoms and flow. Its effectiveness was similar to that of other alpha-antagonists, increasing slightly at higher doses. Adverse effects were generally mild but the incidence, including treatment withdrawals, increased substantially at higher doses.

Humans↗