What are the effects of the fifth revision of the Declaration of Helsinki?
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Controlled Clinical Trials as Topic↗
Biomedical subjects
H A Guess
Publications and source records attributed to H A Guess.
Indinavir did not increase the short-term risk of adverse cardiovascular events relative to nucleoside reverse transcriptase inhibitor therapy in four phase III clinical trials.
A retrospective person-time analysis of the randomized and non-randomized extension phases of four phase III trials was performed to assess the incidence of adverse cardiovascular events in 2680 HIV-infected patients receiving indinavir or nucleoside reverse transcriptase inhibitor therapy, or both. The observed rate of cardiovascular events was not increased in patients receiving indinavir-based regimens compared with therapy without a protease inhibitor. Extrapolation of these findings is limited by the brief length of therapy and the small number of cases.
Anti-HIV Agents↗
Tocolytic therapy for preterm labour: assessing its potential for reducing preterm delivery.
Preterm labour (PTL) is a major contributor to preterm delivery (PTD) but delivery is often not preventable by current therapies. We conducted this study to determine the proportion of women with PTL who were and who were not candidates for tocolytic therapy. The cohort comprised residents of Olmsted County, Minnesota who delivered at >20 weeks' gestation in 1985--94 and who experienced PTL. Medical records were abstracted to identify episodes of PTL, its treatment and outcome. We developed an algorithm that accounted for gestation at delivery and pregnancy complications to determine the proportion of pregnancies complicated by PTL that were candidates for tocolytic therapy. Of 651 pregnancies complicated by PTL, a 50% probability sample, stratified by delivery year, were selected and abstracted. The cumulative incidence of PTL ranged from 3.6 to 6.4 per 100 deliveries of live or stillborn infants. Tocolysis was not contraindicated for 49.4% of all women with PTL and for a third of women with only one PTL episode. Delivery was delayed to >35 weeks in 53.8% of candidates for tocolysis. Only an additional 11.7% of women with one or more PTL episodes could have had their PTD delayed beyond 35 weeks if a perfect tocolytic therapy had been available. Many pregnancies complicated by PTL occurred at > or =35 weeks or involved maternal or obstetric factors that contraindicated tocolytic medications. The maximum incremental benefit that could be expected of a new safe and efficacious tocolytic therapy would be to reduce current PTD rates resulting from PTL by about 12%.
Adolescent↗
Benign prostatic hyperplasia and prostate cancer.
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DNA↗
Effect of vaccination by community pharmacists among adult prescription recipients.
BACKGROUND: Millions of doses of influenza vaccine are administered each year in the United States at nontraditional sites and by nontraditional vaccine providers. Pharmacists are increasingly becoming vaccine providers. OBJECTIVES: To measure association between availability of pharmacist-immunizers and immunization delivery to adult prescription recipients, and the relative contributions of various types of vaccine providers. RESEARCH DESIGN: Mailed survey in spring 1999, contrasting adults in urban Washington State, where pharmacists administer vaccines, to adults in urban Oregon, where pharmacists did not. SUBJECTS: Cluster sample based on October 1998 prescription records suggesting need for influenza vaccine, derived from 24 community pharmacies belonging to one pharmacy chain. MEASURES: Vaccination status and choice of vaccine provider. RESULTS: Influenza vaccination rates among respondents 65 years or older increased 4.7% more in Washington than in Oregon between 1997 and 1998 (P = 0.20). The net increase in influenza vaccination rate among younger respondents taking indicator medications for chronic diseases for which influenza vaccination is recommended was 10.6% (P = 0.05). Among respondents unvaccinated against influenza in 1997, the 1998 influenza vaccination rate was 34.7% in Washington, compared with 23.9% in Oregon (P = 0.01). CONCLUSIONS: Vaccine delivery by pharmacists is associated with higher rates of vaccination among those younger than 65 taking indicator medications medications for chronic diseases, as well as prescription recipients unvaccinated against influenza in the previous year.
Adult↗
Comparative efficiency of prostate-specific antigen screening strategies for prostate cancer detection.
CONTEXT: Despite widespread use of serum prostate-specific antigen (PSA) testing to detect prostate cancer, the relative effectiveness of different PSA screening strategies is unknown. OBJECTIVE: To compare prostate cancer mortality, PSA testing rates, and biopsy rates using various PSA screening strategies, including the standard strategy of annually testing men aged 50 through 75 years. DESIGN AND SETTING: A Monte-Carlo simulation based on a Markov model was used to simulate the natural history of prostate cancer using different starting ages, testing intervals, and PSA thresholds for prostate biopsy. Age-specific PSA levels and prostate biopsy detection probabilities were determined from population data and surgical series. MAIN OUTCOME MEASURES: Numbers of prevented prostate cancer deaths, PSA tests, and prostate biopsies per 1000 men aged 40 through 80 years, compared among 7 different strategies vs no screening. RESULTS: Compared with annual PSA testing beginning at age 50 years, the strategy of PSA testing at ages 40 and 45 years followed by biennial testing beginning at age 50 years was estimated to simultaneously reduce prostate cancer mortality and number of PSA tests and biopsies performed per 1000 men. Specifically, compared with no screening, the standard strategy prevents 3.2 deaths, with an additional 10,500 PSA tests and 600 prostate biopsies, while the earlier but less frequent strategy prevents 3.3 deaths, with an additional 7500 PSA tests and 450 prostate biopsies. Strategies that lowered the PSA threshold for prostate biopsy to below 4.0 ng/mL or strategies that used age-specific PSA levels were not more efficient than use of a PSA threshold of 4.0 ng/mL. These 2 findings remained true under all sensitivity analyses performed to test assumptions of the model. CONCLUSION: Recognizing that the efficacy of PSA screening is unproved, the standard strategy of annual PSA screening beginning at age 50 years appears to be less effective and more resource intensive compared with a strategy that begins earlier but screens biennially instead of annually. JAMA. 2000;284:1399-1405.
Adult↗
Safety and effectiveness of vasectomy.
OBJECTIVE: To recommend further research on vasectomy based on a systematic review of the effectiveness and safety of vasectomy. DESIGN: A systematic MEDLINE review of the literature on the safety and effectiveness of vasectomy between 1964 and 1998. MAIN OUTCOME MEASURE(S): Early failure rates are <1%; however, effectiveness and complications vary with experience of surgeons and surgical technique. Early complications, including hematoma, infection, sperm granulomas, epididymitis-orchitis, and congestive epididymitis, occur in 1%-6% of men undergoing vasectomy. Incidence of epididymal pain is poorly documented. Animal and human data indicate that vasectomy does not increase atherosclerosis and that increases in circulating immune complexes after vasectomy are transient in men with vasectomies. The weight of the evidence regarding prostate and testicular cancer suggests that men with vasectomy are not at increased risk of these cancers. CONCLUSION(S): Publications to date continue to support the conclusion that vasectomy is a highly effective form of contraception. Future studies should include evaluations of the long-term effectiveness of vasectomy, evaluating criteria for postvasectomy discontinuation of alternative contraception for use in settings where semen analysis is not practical, and characterizing complications including chronic epididymal pain syndrome.
Adolescent↗
Measuring injection-site pain associated with vaccine administration in adults: a randomised, double-blind, placebo-controlled clinical trial.
BACKGROUND: Pain at the injection site is one of the most commonly-reported local reactions associated with administration of a vaccine, but it has not been quantified by a validated instrument for pain measurement. We conducted a randomised, double-blind clinical trial to evaluate the measurement characteristics of two commonly-used pain questionnaires, the McGill Present Pain Intensity (PPI) and the Brief Pain Inventory (BPI) Current Pain Question, in the assessment of intramuscular injection-site pain associated with vaccine administration. The PPI measures pain on a scale of 0 (no pain) to 5 (excruciating pain) and the BPI measures pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). METHODS: Two hundred healthy adults were randomised to one of the five regimens: tetanus and diphtheria toxoids adsorbed (Td), aluminum hydroxide adjuvant (alum), physiological saline, or one of the two licensed hepatitis A vaccines, VAQTA, or HAVRIX. Pain assessment was made at eight time-points over a 2-day period after injection. RESULTS: The differences in the time-averaged pain (+/- standard deviation) on the PPI were statistically significant between Td (0.58+/-0.59) and either saline (0.14+/-0.23) (p < 0.005) or alum (0.22+/-0.35) (p < 0.01). Reported time-averaged pain were significantly lower for VAQTA than HAVRIX (p = 0.028). Similar differences were observed for the BPI. CONCLUSIONS: Both instruments have sufficient discriminative validity to distinguish between different levels of injection-site pain in adults.
Adolescent↗
Combination vaccines: issues in evaluation of effectiveness and safety.
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Drug Approval↗
Association of health-related quality of life and benign prostatic enlargement.
OBJECTIVE: To investigate the association of benign prostatic enlargement and health-related quality of life (HRQoL) assessed by validated questionnaires. METHOD: Randomly selected men (n = 471) aged 40-79 years from Olmsted County, Minn. (USA) without prior prostate surgery or prostate cancer had a full urologic workup, including transrectal ultrasonography, in addition to completing questionnaires soliciting information about urinary symptom frequency, bother, degree of interference with daily activities and other measures of HRQoL. RESULTS: Disease-specific HRQoL was worse in older men, and men with more severe symptoms. Age-adjusted mean scores for symptom severity, bother and activity interference were about 50% worse for men with enlarged prostates (volume > 40 cm3). After adjusting for age, men with enlarged prostates were nearly 3 times (95% CI 1.6, 5.1) as likely to have moderate to severe symptoms, and about twice as likely to have bother (odds ratio 2.4; 95% CI 1.3, 4.2) or activity interference (odds ratio 1.8; 95% CI 1. 0, 3.2) relative to men with smaller prostates. CONCLUSION: HRQoL measures are worse in men who are older and, after adjusting for age, in men with increased urinary symptom frequency and enlarged prostate. The broader spectrum of patients provided by the community-based random sampling allows elucidation of these important relationships.
Adult↗
Longitudinal prostate growth rates during 5 years in randomly selected community men 40 to 79 years old.
PURPOSE: We estimate the rate of prostate growth in randomly selected healthy community dwelling men. MATERIALS AND METHODS: Prostate volume in an age stratified random sample of 631 white male residents of Olmsted County, Minnesota 40 to 79 years old without prior prostate surgery or prostate cancer was measured up to 4 times by transrectal ultrasound during a followup period of almost 7 years. RESULTS: Estimated prostate growth rates increased with increasing age. However, the estimated average annual change was 1.6% across all age groups. Estimated prostate growth rates were high depending on baseline prostate volume with higher growth rates for men with larger prostates. CONCLUSIONS: While there is wide variability in prostate growth rates on an individual level, prostate volume appears to increase steadily at about 1.6% per year in randomly selected community men.
Adult↗
Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status.
PURPOSE: We describe treatments for benign prostatic hyperplasia (BPH) among men participating in the Olmsted County study of urinary symptoms and health status among men during 10,000 person-years of followup. MATERIALS AND METHODS: A cohort of 2,115 men 40 to 79 years old was randomly selected from an enumeration of the Olmsted County, Minnesota population (55% response rate). Participants completed a previously validated baseline questionnaire to assess symptom severity and voided into a portable urometer. A 25% random subsample underwent transrectal sonographic imaging of the prostate to determine prostate volume and measurement of serum prostate specific antigen. Followup included retrospective review of community medical records and completion of a biennial questionnaire to determine the occurrence of medical and surgical treatment for BPH in the subsequent 6 years. RESULTS: During more than 10,000 person-years of followup 167 men were treated, yielding an overall incidence of 16.0/1,000 person-years. There was a strong age related increase in risk of any treatment from 3.3/1,000 person-years for men 40 to 49 years old to more than 30/1,000 person-years for those 70 years old or older. Men with moderate to severe symptoms (American Urological Association symptom index greater than 7), depressed peak urinary flow rates (less than 12 ml. per second), enlarged prostate (greater than 30 ml.) or elevated serum prostate specific antigen (1.4 ng./ml. or greater) had about 4 times the risk of BPH treatment than those who did not. After adjustment for all measures simultaneously an enlarged prostate (hazard ratio 2.3, 95% confidence interval [CI] 1.1, 4.7), depressed peak flow rate (hazard ratio 2.7, 95% CI 1.4, 5.3) and moderate to severe symptoms (hazard ratio 5.3, 95% CI 2.5, 11.1) at baseline each independently predicted subsequent treatment. CONCLUSIONS: While repeat contact and availability of urological measurements during the study period may have influenced treatment decisions in this cohort, the data demonstrate that treatment is common in elderly men with nearly 1 in 4 receiving treatment in the eighth decade of life. Furthermore, these data suggest that men with moderate to severe lower urinary tract symptoms, impaired flow rates or enlarged prostates are more likely to undergo treatment, with increases in risk of similar magnitude to those associated with adverse outcomes, such as acute urinary retention.
Adult↗
Health-related quality of life associated with lower urinary tract symptoms in four countries.
OBJECTIVES: To describe health-related quality of life (HRQL) associated with lower urinary tract symptoms (LUTS) assessed by validated questionnaires in four countries. METHODS: More than 6000 men, recruited by using community- or population-based sampling in four countries, completed questionnaires soliciting information about urinary symptom frequency, bother, degree of interference with daily activities, and other measures of HRQL. RESULTS: In all countries, disease-specific HRQL worsened with increasing age. Adjusting for age, most disease-specific HRQL measures were significantly worse with increasing symptom severity. The correlation between symptoms and HRQL was strongest in countries with higher prevalence of symptoms, such as Japan or the United States, and less pronounced in countries with lower prevalence (France, Scotland), possibly reflecting the lower variability in scores. CONCLUSIONS: HRQL measures are worse in older men, and increased urinary symptom severity is associated with worse disease-specific HRQL in all countries, despite potential cross-cultural differences in disease prevalence, medication use, perceptions, or willingness to report symptoms or worse HRQL. This cross-cultural consistency suggests that an assessment of symptom bother or interference with daily activities may be useful in patient evaluation.
Adult↗
Screening digital rectal examination and prostate cancer mortality: a population-based case-control study.
OBJECTIVES: Although digital rectal examination (DRE) for the detection of prostate cancer has been recommended by many professional groups and has become part of the general physical examination, no randomized clinical trial has demonstrated the efficacy or effectiveness of this practice. We conducted a population-based case-control study to evaluate the association between DRE and prostate cancer mortality. METHODS: With the resources of the Rochester Epidemiology Project, all 173 men who died of prostate cancer in Olmsted County from 1976 to 1991, who were resident at the time of diagnosis, were identified. For each case, two control patients were drawn from the population, matched for residence at the time of diagnosis in the case, birth date, and duration of medical record in Olmsted County. Trained nurse abstractors reviewed the community medical records for up to 10 years before the date of diagnosis in the case for mention of DRE and specific findings associated with each mention. RESULTS: Case subjects were less likely than control subjects to have had any DRE in the 10 years before diagnosis (matched odds ratio [OR] = 0.51; 95% confidence interval [CI] = 0.31, 0.84). When limited to DREs without mention of signs or symptoms that might raise suspicion of prostate cancer, the association was even stronger (OR = 0.31; 95% CI = 0.19, 0.49). Adjustment for educational attainment, marital status, and comorbid conditions did little to alter the associations. CONCLUSIONS: These results demonstrate a strong inverse association between DRE and prostate cancer mortality. If further research concludes this association to be causal, screening DREs may have prevented as many as 50% to 70% of deaths due to prostate cancer that might have occurred in the absence of screening.
Aged↗
Treatment with finasteride preserves usefulness of prostate-specific antigen in the detection of prostate cancer: results of a randomized, double-blind, placebo-controlled clinical trial. PLESS Study Group. Proscar Long-term Efficacy and Safety Study.
OBJECTIVES: To evaluate prostate cancer detection and prostate-specific antigen (PSA) among men with benign prostatic hyperplasia treated with finasteride. METHODS: Three thousand forty men 45 to 78 years of age with PSA less than 10 ng/mL and no history of prostate cancer were randomized in a double-blind, placebo-controlled trial to finasteride (n = 1524) or placebo (n = 1516) for up to 4 years. A prerandomization biopsy negative for prostate cancer was obtained in 98% of patients with a screening PSA of 4.0 ng/mL or more, and an end-of-study biopsy was requested of all such patients without a recent second negative biopsy or a prostate cancer diagnosis. RESULTS: Overall, 644 patients (21%) underwent biopsy and 201 (6.6%) underwent transurethral resection of the prostate. Prostate cancer was diagnosed in 4.7% of men on finasteride and 5.1% on placebo (P = 0.7). Elevated PSA prompted diagnosis in 35% of cases on finasteride and 34% on placebo. The area under the receiver operating characteristic curve for last PSA was 0.84 on finasteride and 0.79 on placebo (P = 0.07). Use of an upper limit of normal for last PSA of 2.0 ng/mL for finasteride and 4.0 ng/mL for placebo yielded similar sensitivity (66% versus 70%, P = 0.6), higher specificity (82% versus 74%, P < 0.0001), and a higher likelihood ratio (3.6 versus 2.7, P < 0.05) for finasteride than for placebo. CONCLUSIONS: In men treated with finasteride, multiplying PSA by 2 and using normal ranges for untreated men preserves the usefulness of PSA for prostate cancer detection.
Aged↗
Cost of varicella in France: a study in day care centers.
To assess the cost of varicella in young children in France, a prospective study was done in day care centers. Children (1263), who were 3 months to 3 years old and attending day care, were followed over a varicella season. For every child who developed varicella (n = 200), detailed information was obtained by use of parental questionnaires. Questions concerned medical care, days missed from work for parents, and the need for extra baby-sitting. On average, each sick child had one consultation with a physician and received three medications. In half of the families (52%), at least 1 parent had to miss work an average of 4.5 days to care for a sick child. Total costs to society were estimated to be US$352 per family, with medical costs accounting for 22% of the cost. The average eventual cost to parents was $89 per family, including $80 of non-medical costs. This study emphasizes the important socioeconomic impact of varicella in the day care setting in France.
Chickenpox↗
Natural history of prostatism: risk factors for acute urinary retention.
PURPOSE: We determined the occurrence of and risk factors for acute urinary retention in the community setting. MATERIALS AND METHODS: A cohort of 2,115 men 40 to 79 years old was randomly selected from an enumeration of the Olmsted County, Minnesota population (55% response rate). Participants completed a previously validated baseline questionnaire that assessed symptom severity, and voided into a portable urometer to measure peak urinary flow rates. A 25% random subsample underwent transrectal sonographic imaging of the prostate to determine prostate volume. Followup was performed through a retrospective review of community medical records to determine the occurrence of acute urinary retention in the subsequent 4 years. RESULTS: During the 8,344 person-years of followup 57 men had a first episode of acute urinary retention (incidence 6.8/1,000 person-years, 95% confidence interval [CI] 5.2, 8.9). Among men with no to mild symptoms (American Urological Association symptom index score 7 or less) the incidence of acute urinary retention increased from 2.6/1,000 person-years among men 40 to 49 years old to 9.3/1,000 person-years among men 70 to 79 years old. By contrast, rates increased from 3.0/1,000 person-years for men 40 to 49 years old to 34.7/1,000 person-years among men 70 to 79 years old among men with moderate to severe symptoms (American Urological Association symptom index score greater than 7). Men with depressed peak urinary flow rate (less than 12 ml. per second) were at 4 times the risk of acute urinary retention compared with men with urinary flow rates greater than 12 ml. per second (95% CI 2.3, 6.6). Men with an enlarged prostate (greater than 30 ml.) experienced a 3-fold increase in risk (95% CI 1.0, 9.0, p = 0.04). CONCLUSIONS: Lower urinary tract symptoms, depressed peak urinary flow rates, enlarged prostates and older age are associated with an increased risk of acute urinary retention in community dwelling men. These findings may help to identify men at increased risk of acute urinary retention in whom closer evaluation may be warranted.
Acute Disease↗
Natural history of prostatism: impaired health states in men with lower urinary tract symptoms.
PURPOSE: Lower urinary tract symptoms are reported to have a significant impact on quality of life. However, the impact on specific aspects of health status is not clear. We evaluated the association between lower urinary tract symptoms, and physical and mental aspects of health using community based data from a cross-sectional component of a prospective cohort study. MATERIALS AND METHODS: A total of 2,133 men 41 to 84 years old who were randomly selected from the Olmsted County, Minnesota population completed the 36-item health status questionnaire and a previously validated questionnaire assessing urinary symptoms. Eight domains, measured on a scale of 0 to 100, were used to assess general health status. Men were classified as having an impaired health status if they scored less than 75 points on the scale. Symptom severity (none, mild, moderate or severe) was measured from responses to the urinary symptom questionnaire. RESULTS: The results demonstrated a cross-sectional decrease in mean health status scores for all 8 domains across levels of increasing urinary symptom severity. The strongest associations between health status scores and urinary symptoms (severe versus none) were observed for role limitation due to physical problems (odds ratio 15.7, 95% confidence interval 6.6 to 37.0), energy/fatigue (odds ratio 9.2, 95% confidence interval 4.7 to 18.1), role limitation due to emotional problems (odds ratio 8.7, 95% confidence interval 4.1 to 18.2) and general perception of health (odds ratio 7.2, 95% confidence interval 3.8 to 13.4). For these 4 dimensions men with mild urinary symptoms were also significantly more likely to have an impaired health status. Adjustment for age and co-morbidity did not alter the results. CONCLUSIONS: These findings suggest that urinary symptoms have a multidimensional association with physical and mental aspects of health. Although lower urinary tract symptoms may be the cause of an impaired health status, men with impaired health conditions may be more sensitive to prevalent urinary symptoms and more likely to report them. While the casual nature of this association has not been ascertained, these results may help to identify appropriate health dimensions to assess in patients with lower urinary tract symptoms.
Adult↗