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Biomedical subjects

Frank A Lederle

Publications and source records attributed to Frank A Lederle.

At least 19 recordsLinked to original sources
PubMed2006

Should patients with anemia and low normal or normal serum ferritin undergo colonoscopy?

BACKGROUND: Patients with unexplained iron deficiency anemia have a greater prevalence of colonic neoplasia, and should be evaluated for a colonoscopy. The approach to patients with anemia without iron deficiency remains unclear. OBJECTIVE: To compare the prevalence of colonic neoplasia in anemic patients with normal ferritin (>50 ng/mL), to those with ferritin < or =50 ng/mL, and nonanemic individuals. METHODS: Patients referred for colonoscopy for anemia evaluation were stratified into 3 groups: ferritin < or =50 ng/mL, 51-100 ng/mL, and >100 ng/mL. We compared these groups to each other, and to asymptomatic nonanemic individuals undergoing screening colonoscopy. The prevalence of advanced colonic neoplasia was determined for each group using existing records. RESULTS: During the study period, 414 patients who underwent colonoscopy for anemia evaluation and 323 nonanemic individuals who underwent colonoscopy for cancer screening met inclusion criteria. Study subjects were mostly men. The prevalence of advanced colonic neoplasia in subjects with ferritin 51-100 ng/mL was 7.2% (95% CI 2.4-17.9%), similar to 7.9% (95% CI 5.1-11.9%) in those with ferritin < or =50 ng/mL. The incidence of advanced colonic neoplasia in subjects with ferritin >100 ng/mL was 1.7% (95% CI 0.1-6.6%), similar to 1.2% (95% CI 0.4-3.3%) in the asymptomatic nonanemic group. After adjusting for age, patients with ferritin < or =50 ng/mL and 51-100 ng/mL were almost 5 times more likely to harbor advanced colonic neoplasia than the other groups. The addition of other laboratory parameters did not improve the predictive value of ferritin. CONCLUSION: A ferritin cutoff of 100 ng/mL can be used to determine the need for colonoscopy in men with anemia.

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PubMed2006

Colorectal cancers found after a complete colonoscopy.

BACKGROUND & AIMS: The incidence of colorectal cancer in patients undergoing colonoscopic surveillance is higher than previously thought. A better understanding of interval cancers is needed to improve surveillance strategies. The objectives of this study were to determine whether interval colorectal cancers were associated with an inadequate earlier colonoscopy, incomplete polypectomy, or aggressive biologic behavior. METHODS: We searched our institution's cancer registry. Interval cancers were defined as colorectal cancers that developed within 5 years of a complete colonoscopy. These were frequency matched in a 1:2 ratio to patients with sporadic cancers, which were defined as colorectal cancers diagnosed on a patient's first recorded colonoscopy. Patient, colonoscopy, and tumor characteristics of interval and sporadic cancers were compared. RESULTS: Of the 830 colorectal cancers diagnosed during the study period, 45 patients developed an interval cancer (5.4%; 95% confidence interval, 4.1%-7.2%). Twenty-seven percent of interval cancers developed at previous polypectomy segments, and location of polypectomy segments was predictive of the location of subsequent interval cancers. Interval cancers were 3 times more likely to occur in the right colon and were smaller in size than sporadic cancers. Quality of bowel preparation, individual endoscopist, endoscopist experience, and trainee involvement were not associated with interval cancers. No difference in TNM stage at diagnosis, histologic type or grade, carcinoembryonic antigen level, or 5-year survival was found between interval and sporadic cancers. CONCLUSIONS: Incomplete polypectomy might play an important role in the development of interval colorectal cancer. No association between other colonoscopy-related factors or tumor characteristics and interval cancers was found.

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PubMed2006

Endoscopic ultrasound and positron emission tomography for lung cancer staging.

BACKGROUND AND AIMS: Accurate assessment of mediastinal lymph nodes is vital for optimum treatment allocation in lung cancer patients. Currently available strategies fail to identify many patients with advanced mediastinal disease, resulting in unnecessary surgery. We prospectively compared 2 promising new modalities, positron emission tomography (PET) and endoscopic ultrasound (EUS), for staging mediastinal lymph nodes. METHODS: Consenting patients with lung cancer who also were suitable candidates for surgery were enrolled in the study. Patients underwent both PET and EUS. Outcomes were analyzed by surgery results or follow-up with serial imaging. RESULTS: Seventy-two eligible patients were enrolled, and adequate data were available for 65 patients. The final diagnosis was based on tissue analysis in 59 patients and 1-year radiologic follow-up evaluation in 6 patients. PET correctly diagnosed mediastinal lymph node status in 77% of patients, and EUS fine-needle aspiration was correct in 94% of patients (P = .012). The overall sensitivity, specificity, and accuracy of PET were 61%, 91%, and 77% compared with 87%, 100%, and 94% for EUS. We estimated that EUS obviated a surgical procedure in 55% (95% confidence interval, 40%-69%) of patients with radiologic evidence of mediastinal metastasis, and in 22% (95% confidence interval, 10%-41%) of patients without radiologic evidence of mediastinal metastasis. CONCLUSIONS: EUS fine-needle aspiration was more accurate than PET in staging mediastinal lymph nodes in lung cancer patients, and resulted in a substantial reduction in mediastinoscopy and thoracotomy.

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PubMed2006

The prophylaxis of medical patients for thromboembolism pilot study.

PURPOSE: We assessed the feasibility of a large randomized trial intended to determine whether low-dose heparin prophylaxis given throughout hospitalization reduces mortality and morbidity in general medical patients. SUBJECTS AND METHODS: Hospitalized general medical patients aged more than 60 years at 5 Department of Veterans Affairs (VA) medical centers were randomized to receive enoxaparin 40 mg or identical placebo, given daily by subcutaneous injection until hospital discharge. Outcomes included total mortality at 90 days (the primary outcome) and 1 year, and occurrence in the VA hospital within 90 days of symptomatic deep venous thrombosis, pulmonary embolism, and major bleeding. RESULTS: Only 7.6% of hospitalized patients aged more than 60 years were eligible for the study, although a chart review had predicted 25%. The principal exclusions were prior indication for anticoagulation, anticipated need for anticoagulation, contraindication to heparin, expected hospitalization less than 3 days, and "supportive/palliative care only" status. We randomized 140 patients into each group, 28% of target recruitment. The groups were well matched by age and comorbidities. Death occurred in 13 patients receiving enoxaparin and 14 patients receiving placebo at 90 days (relative risk 0.93, 95% confidence interval 0.26-1.59), and in 36 and 32 patients, respectively, at 1 year (relative risk 1.13, 95% confidence interval 0.66-1.60). Clinical thromboembolic events occurred in 5 patients receiving enoxaparin and 8 patients receiving placebo, and major bleeding occurred in 2 and 5 patients, respectively. CONCLUSIONS: The pilot study indicated that the full study was not feasible. The decision to use prophylaxis pertains to only a small proportion of general medical patients hospitalized at VA medical centers, and this proportion is overestimated by chart review. The effect of low-dose heparin prophylaxis on clinical outcomes in hospitalized general medical patients remains uncertain.

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PubMed2006

EUS-guided FNA for the diagnosis of advanced lung cancer.

BACKGROUND: A majority of patients with lung cancer are incurable but are symptomatic and may benefit from palliative therapy. Currently available diagnostic methods are either too risky or unsuccessful in obtaining a tissue diagnosis in up to 30% of patients. OBJECTIVE: To evaluate the role of EUS-guided FNA in obtaining a tissue diagnosis in patients with advanced lung cancer. DESIGN: Prospective, uncontrolled. SETTING: Veterans Administration Medical Center. SUBJECTS AND METHODS: Patients with suspected lung cancer who were not candidates for curative therapy were prospectively identified. CT scans were reviewed, and patients with lesions considered suitable for sampling by EUS were enrolled. Outcomes were analyzed by a final tissue diagnosis or by serial imaging. RESULTS: Sixty-nine patients met inclusion criteria, of which 3 refused participation. The remaining 66 patients constituted the study population. EUS was technically successful in 95% of patients. A final diagnosis was based on tissue in 63 of 66 patients, serial imaging in 1 of 66 patients, and was unavailable in 2 of 66 patients. A lung mass was sampled in 21 patients, and a metastatic lesion was sampled in 45 patients. EUS made a correct diagnosis in 55 of 64 patients (86%, 95% confidence interval [CI] 77%-93%), including 24% that had undergone a failed prior attempt at diagnosis. The sensitivity of EUS was 86%, and the specificity was 100%. Sampling a metastasis was more likely to yield a correct diagnosis than sampling a lung mass (P = .02). Two self-limited complications were noted during the study. CONCLUSIONS: EUS was an accurate and a safe method for obtaining a tissue diagnosis in patients with advanced incurable lung cancer.

Adult↗
PubMed2006

Microsatellite instability in interval colon cancers.

BACKGROUND & AIMS: Colon cancers that develop after a complete colonoscopy may be the result of "failure of colonoscopy" or rapid tumor growth. Tumors that develop via the mismatch repair gene pathway demonstrate rapid tumor growth. The aim of this study was to determine if interval colon cancers were more likely than noninterval cancers to result from the loss of function of mismatch repair genes and hence demonstrate microsatellite instability (MSI). METHODS: We searched our institution's cancer registry for interval cancers, defined as colon cancers that developed within 5 years of a complete colonoscopy. These were frequency matched in a 1:2 ratio by age and sex to patients with noninterval cancers (defined as colon cancers diagnosed on a patient's first recorded colonoscopy). Archived cancer specimens for all subjects were retrieved and tested for MSI. RESULTS: Of the 993 colon cancers diagnosed during the study period, 51 (5.1%) were identified as an interval cancer, and 112 subjects with noninterval cancer served as a comparison group. Study subjects were almost all men. MSI was found in 30.4% of interval cancers compared with 10.3% of noninterval cancers (P = .003). After adjusting for age, interval cancers were 3.7 times more likely to show MSI than noninterval cancers (95% confidence interval, 1.5-9.1). This association was strongest for tumors located in the distal colon (odds ratio, 17.5; P = .008). No difference in TNM stage at diagnosis, histologic type or grade, or 5-year survival was found between groups. CONCLUSIONS: Interval colon cancers were almost 4 times as likely as noninterval colon cancers to be associated with mismatch repair gene dysfunction.

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PubMed2006

A summary of the contributions of the VA cooperative studies on abdominal aortic aneurysms.

The Department of Veterans Affairs Cooperative Studies Program has completed two studies on abdominal aortic aneurysm (AAA) and is currently conducting a third. The first, the Aneurysm Detection and Management (ADAM) Study, consisted of both a screening program, which provided information on the prevalence and associations of AAA, and a randomized trial, which found that survival is not improved by repair of small AAA. The second was a prospective observational study to determine the incidence of rupture in patients with large AAA for whom elective repair was not planned due to medical contraindications or patient refusal. AAA in this population had a high risk of rupture, about 10% per year for AAA > 5.5 cm, and 25% within 6 months for AAA larger than 8.0 cm. The third, the Open Versus Endovascular Repair (OVER) Trial, is a multicenter randomized trial comparing long-term survival following two methods of elective AAA repair.

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PubMed2005

Screening for abdominal aortic aneurysm: a best-evidence systematic review for the U.S. Preventive Services Task Force.

BACKGROUND: While the prognosis for abdominal aortic aneurysm (AAA) rupture is poor, ultrasound imaging is an accurate and reliable test for detecting AAAs before rupture. PURPOSE: To examine the benefits and harms of population-based AAA screening. DATA SOURCES: MEDLINE (1994 to July 2004) supplemented by the Cochrane Library, a reference list of retrieved articles, and expert suggestions. STUDY SELECTION: Randomized trials of AAA population screening, population studies of AAA risk factors, and data on adverse screening and treatment events from randomized trials and cohort studies. DATA EXTRACTION: All studies were reviewed, abstracted, and rated for quality by using predefined criteria. DATA SYNTHESIS: The authors identified 4 population-based randomized, controlled trials of AAA screening in men 65 years of age and older. On the basis of meta-analysis, an invitation to attend screening was associated with a significant reduction in AAA-related mortality (odds ratio, 0.57 [95% CI, 0.45 to 0.74]). A meta-analysis of 3 trials revealed no significant difference in all-cause mortality (odds ratio, 0.98 [CI, 0.95 to 1.02]). No significant reduction in AAA-related mortality was found in 1 study of AAA screening in women. Screening does not appear to be associated with significant physical or psychological harms. Major treatment harms include an operative mortality rate of 2% to 6% and significant risk for major complications. LIMITATIONS: The population screening studies focused on men and provided no information on racial or ethnic groups. No information was available on uninvited control group characteristics, so the importance of risk factors such as tobacco use or family history could not be assessed. Since all trials were conducted in countries other than the United States, generalizability to the U.S. population is uncertain. CONCLUSION: For men age 65 to 75 years, an invitation to attend AAA screening reduces AAA-related mortality.

Advisory Committees↗
PubMed2005

Pulse versus continuous terbinafine for onychomycosis: a randomized, double-blind, controlled trial.

BACKGROUND: Effective treatments for onychomycosis are expensive. Previous studies suggest that less costly, pulsed doses of antifungal medications may be as effective as standard, continuous doses. Terbinafine is the current treatment of choice for toenail onychomycosis. OBJECTIVE: Our purpose was to determine whether pulse-dose terbinafine is as effective as standard continuous-dose terbinafine for treatment of toenail onychomycosis. METHODS: We conducted a double-blind, randomized, noninferiority, clinical intervention trial in the Minneapolis Veterans Affairs Medical Center. The main inclusion criteria for participants were a positive dermatophyte culture and at least 25% distal subungual clinical involvement. Six hundred eighteen volunteers were screened; 306 were randomized. Terbinafine, 250 mg daily for 3 months (continuous) or terbinafine, 500 mg daily for 1 week per month for 3 months (pulse) was administered. The primary outcome measure was mycological cure of the target toenail at 18 months. Secondary outcome measures included clinical cure and complete (clinical plus mycological) cure of the target toenail and complete cure of all 10 toenails. RESULTS: Results of an intent-to-treat analysis did not meet the prespecified criterion for noninferiority but did demonstrate the superiority of continuous-dose terbinafine for: mycological cure of the target toenail (70.9% [105/148] vs 58.7% [84/143]; P =.03, relative risk [RR] of 1.21 [95% confidence interval (CI), 1.02-1.43]); clinical cure of the target toenail (44.6% [66/148] vs 29.3% [42/143]; P =.007, RR =1.52 [95% CI, 1.11-2.07); complete cure of the target toenail (40.5% [60/148] vs 28.0% [40/143]; P =.02, RR=1.45 [95% CI, 1.04-2.01); and complete cure of all 10 toenails (25.2% [36/143] vs 14.7% [21/143]; P =.03, RR =1.71 [95% CI, 1.05-2.79). Tolerability of the regimens did not differ significantly between the groups (chi2 =1.63; P =.65). LIMITATIONS: The study population primarily consisted of older men with severe onychomycosis. CONCLUSIONS: This study demonstrated the superiority of continuous- over pulse-dose terbinafine. We also found this expensive therapy to be much less effective than previously believed, particularly for achieving complete cure of all 10 toenails.

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PubMed2003

Ultrasonographic screening for abdominal aortic aneurysms.

Abdominal aortic aneurysms (AAAs) occur in 1 of 20 older men, remain asymptomatic for many years, and, if left untreated, cause death from rupture in about one third of patients. Ultrasonography is a suitable screening test for AAA, and elective repair can prevent rupture. Although these features suggest a promising target for a screening program, evidence of benefit from AAA screening has only recently become available. Four randomized trials of ultrasonographic screening involving more than 125 000 men have been reported, and each trial observed a reduction in AAA-related mortality (which was statistically significant in 2 trials), ranging from 21% to 68%. One trial in women found no benefit. Other studies indicate that screening can begin in men older than 65 years of age and does not need to be repeated if results are negative. An AAA larger than 5.5 cm in diameter should be considered for elective open or endovascular repair. Most aneurysms detected at screening are smaller and should be kept under surveillance with periodic imaging measurement. Widespread elective repair of small AAAs could reduce the benefits and increase the costs of screening. No medical treatments have been proven to reduce the enlargement rate. If elective repair is reserved for larger AAAs, one-time ultrasonographic screening for AAA can be recommended for men 65 to 79 years of age who have ever smoked [correction].

Aortic Aneurysm, Abdominal↗
PubMed2003

Smokers' relative risk for aortic aneurysm compared with other smoking-related diseases: a systematic review.

OBJECTIVE: Aortic aneurysm has traditionally been considered a manifestation of atherosclerosis, but recent evidence suggests an independent pathogenesis, possibly similar to that of chronic obstructive pulmonary disease (COPD). Further insight into the pathogenesis of aortic aneurysm might be obtained by comparing its association with smoking with that of other smoking-related diseases. STUDY DESIGN: We conducted a systematic review of studies providing relative risk associated with smoking for both aortic aneurysm and other smoking-related diseases. RESULTS: We identified 10 eligible studies, which included more than 3 million subjects. The events reported in 9 studies were death from target diseases; the tenth study reported new diagnoses. Relative risk for aortic aneurysm-related events in current smokers was generally 3 to 6, compared with 1 to 2 for coronary artery disease or cerebrovascular disease and 5 to 12 for COPD. For each category of smoking in each study, relative risk associated with smoking was substantially greater for aortic aneurysm than for coronary artery disease or cerebrovascular disease. Our pooled estimates indicate that, in men, the association of ever smoking with aortic aneurysm is 2.5 times greater than the association of ever smoking with coronary artery disease (95% confidence interval [CI], 2.2, 2.8) and 3.5 times greater than the association of ever smoking with cerebrovascular disease (95% CI, 2.4, 5.3), but only 0.56 as great as the association of ever smoking with COPD (95% CI, 0.36, 0.86). CONCLUSIONS: The difference in magnitude of these associations with smoking is consistent with a non-atherosclerotic cause for aortic aneurysm and/or a stronger effect of smoking on vascular disease in the peripheral arteries.

Aortic Aneurysm↗
PubMed2003

Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of small abdominal aortic aneurysm.

OBJECTIVE: We compared long-term health-related quality-of-life outcome after randomization to immediate elective repair or imaging surveillance, and in relation to time of elective repair, in patients with small asymptomatic abdominal aortic aneurysm (AAA). METHODS: This randomized clinical trial was carried out in 16 Veterans Affairs medical centers. Study subjects were patients at good surgical risk, aged 50 to 79 years, with AAAs 4.0 to 5.4 cm in diameter. Interventions included immediate open surgical AAA repair or imaging surveillance every 6 months with repair reserved for AAAs that became symptomatic or enlarged to 5.5 cm. Main outcome measures considered were SF-36 health status questionnaire, prevalence of impotence, and maximum activity level, which were determined at randomization and at all follow-up visits. RESULTS: Eleven hundred thirty-six patients were randomized and followed up for 3.5 to 8 years (mean, 4.9 years). The two randomized groups did not differ significantly for most SF-36 scales at most times, but the immediate repair group scored higher overall in general health (P <.0001), which was particularly evident in the first 2 years after randomization, and slightly lower in vitality (P <.05). The baseline value of one SF-36 scale, physical functioning, was an independent predictor of mortality. Overall, more patients became impotent after randomization to immediate repair compared with surveillance (P <.03), but this difference did not become apparent until more than 1 year after randomization. Maximum activity level did not differ significantly between the two randomized groups, but decline over time was significantly greater in the immediate repair group (P <.02). CONCLUSIONS: For most quality-of-life measures and times there was no difference between randomized groups. Immediate repair resulted in a higher prevalence of impotence more than 1 year after randomization, but was also associated with improved perception of general health in the first 2 years.

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