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Biomedical subjects

Dale F Kraemer

Publications and source records attributed to Dale F Kraemer.

14 recordsLinked to original sources

Depression decision support in primary care: a cluster randomized trial.

BACKGROUND: Intensive collaborative interventions improve depression outcomes, but the benefit of less intensive interventions is not clear. OBJECTIVE: To determine whether decision support improves outcomes for patients with depression. DESIGN: Clinician-level, cluster randomized, controlled trial. SETTING: 5 primary care clinics of 1 Veterans Affairs medical center. PARTICIPANTS: 41 primary care clinicians, and 375 patients with depression (Patient Health Questionnaire [PHQ-9] depression scores of 10 to 25 or Hopkins Symptom Checklist-20 [SCL-20] scores > or = 1.0). MEASUREMENTS: The primary outcome was change in depression score (SCL-20) at 6 and 12 months. Secondary outcomes were health-related quality-of-life (36-item Short Form for Veterans [SF-36V] score), patient satisfaction, antidepressant use, and health care utilization. INTERVENTION: Clinicians received depression education and were randomly assigned to depression decision support or usual care. The depression decision support team, which consisted of a psychiatrist and nurse, provided 1 early patient educational contact and depression monitoring with feedback to clinicians over 12 months. RESULTS: Although SCL-20 depression scores improved in both groups, the intervention had no effect compared with usual care. The difference in slopes comparing intervention and control over 12 months was 0.20 (95% CI, -0.37 to 0.78; P = 0.49), which was neither clinically nor statistically significant. Changes in SF-36V scores also did not differ between groups. At 12 months, intervention patients reported greater satisfaction (P = 0.002) and were more likely to have had at least 1 mental health specialty appointment (41.1% vs. 27.2%; P = 0.025), to have received any antidepressant (79.3% vs. 69.3%; P = 0.041), and to have received antidepressants for 90 days or more (76.2% vs. 61.6%; P = 0.008). LIMITATIONS: Usual care clinicians received depression education and had on-site mental health support, which may have mitigated intervention effectiveness. CONCLUSIONS: Decision support improved processes of care but not depression outcomes. More intensive care management or specialty treatment may be needed to improve depression outcomes.

Adult↗

Enhancing access to the Bibliome: the TREC 2004 Genomics Track.

BACKGROUND: The goal of the TREC Genomics Track is to improve information retrieval in the area of genomics by creating test collections that will allow researchers to improve and better understand failures of their systems. The 2004 track included an ad hoc retrieval task, simulating use of a search engine to obtain documents about biomedical topics. This paper describes the Genomics Track of the Text Retrieval Conference (TREC) 2004, a forum for evaluation of IR research systems, where retrieval in the genomics domain has recently begun to be assessed. RESULTS: A total of 27 research groups submitted 47 different runs. The most effective runs, as measured by the primary evaluation measure of mean average precision (MAP), used a combination of domain-specific and general techniques. The best MAP obtained by any run was 0.4075. Techniques that expanded queries with gene name lists as well as words from related articles had the best efficacy. However, many runs performed more poorly than a simple baseline run, indicating that careful selection of system features is essential. CONCLUSION: Various approaches to ad hoc retrieval provide a diversity of efficacy. The TREC Genomics Track and its test collection resources provide tools that allow improvement in information retrieval systems.

Journal Article↗

Toxicity profile of delayed high dose sodium thiosulfate in children treated with carboplatin in conjunction with blood-brain-barrier disruption.

PURPOSE: To assess the safety of delayed high dose intravenous (i.v.) sodium thiosulfate (STS) in a case series of 12 children with malignant brain tumors who were treated with intraarterial (i.a.) carboplatin in conjunction with blood-brain-barrier disruption (BBBD). METHODS: Twelve children ages 17 months-12 years underwent a total of 132 BBBD chemotherapy treatments and also received delayed high dose STS (i.v.). Dose 1 of STS (10-16 g/m(2)) was administered 2 or 4 hr after carboplatin, and a second STS dose was administered 4 hr after dose 1 if the child had impaired baseline hearing. Toxicity data were graded in accordance with the National Cancer Institute Common Toxicity Criteria (Version 2). Audiologic monitoring to evaluate the otoprotective potential of STS was performed on 11 children. Ototoxicity was defined in accordance with the American Speech-Language-Hearing Association (ASHA) criteria. Baseline and end of treatment hearing status were graded using Brock's criteria. RESULTS: Nausea and vomiting were well controlled with anti-emetics administered approximately 30 min prior to STS infusion. Analogous to results in adult patients, there was mild transient hypernatremia and a trend for improved protection from ototoxicity in children who received STS delayed to 4 hr post-treatment versus 2 hr. Tumor responses were seen in heavily pre-treated patients with relatively chemo-resistant tumors, suggesting that STS did not protect the tumor from platinum cytotoxicity. CONCLUSION: High dose STS is well tolerated in children under 12 years of age. Further studies of STS in children are warranted to assess otoprotection and the impact of STS on platinum mediated efficacy.

Antineoplastic Agents↗

Ototoxicity in children receiving platinum chemotherapy: underestimating a commonly occurring toxicity that may influence academic and social development.

PURPOSE: To describe the frequency and severity of ototoxicity in a series of pediatric patients treated with platinum-based chemotherapy. PATIENTS AND METHODS: Serial audiologic evaluations were conducted for 67 patients aged 8 months to 23 years who received platinum-based chemotherapy. Audiologic data was analyzed to determine time to hearing-loss using American Speech-Language-Hearing Association (ASHA) criteria, and the effects of treatment and patient characteristics on the incidence and severity of ototoxicity. RESULTS: Bilateral decreases in hearing were seen in 61% of patients (median time to hearing loss, 135 days). Children treated for medulloblastoma, osteosarcoma, and neuroblastoma had greater incidence and severity of hearing loss. Agreement between the usually reported National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and ASHA criteria was inadequate. CONCLUSION: Traditional reporting of toxicity data (CTCAE) has under-reported ototoxicity and minimized the significance of hearing loss in children. As pediatric patients experience improved survival, the effects and implications of high-frequency hearing loss with regard to academic achievement and speech and language development are important considerations, especially in patients younger than 5 years.

Adolescent↗

Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial.

CONTEXT: Clinical studies of omega-3 polyunsaturated fatty acids (PUFAs) have shown a reduction in sudden cardiac death, suggesting that omega-3 PUFAs may have antiarrhythmic effects. OBJECTIVE: To determine whether omega-3 PUFAs have beneficial antiarrhythmic effects in patients with a history of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). DESIGN AND SETTING: Randomized, double-blind, placebo-controlled trial performed at 6 US medical centers with enrollment from February 1999 until January 2003. PATIENTS: Two hundred patients with an implantable cardioverter defibrillator (ICD) and a recent episode of sustained VT or VF. INTERVENTION: Patients were randomly assigned to receive fish oil, 1.8 g/d, 72% omega-3 PUFAs, or placebo and were followed up for a median of 718 days (range, 20-828 days). MAIN OUTCOME MEASURES: Time to first episode of ICD treatment for VT/VF, changes in red blood cell concentrations of omega-3 PUFAs, frequency of recurrent VT/VF events, and predetermined subgroup analyses. RESULTS: Patients randomized to receive fish oil had an increase in the mean percentage of omega-3 PUFAs in red blood cell membranes from 4.7% to 8.3% (P<.001), with no change observed in patients receiving placebo. At 6, 12, and 24 months, 46% (SE, 5%), 51% (5%), and 65% (5%) of patients randomized to receive fish oil had ICD therapy for VT/VF compared with 36% (5%), 41% (5%), and 59% (5%) for patients randomized to receive placebo (P = .19). In the subset of 133 patients whose qualifying arrhythmia was VT, 61% (SE, 6%), 66% (6%), and 79% (6%) of patients in the fish oil group had VT/VF at 6, 12, and 24 months compared with 37% (6%), 43% (6%), and 65% (6%) of patients in the control group (P = .007). Recurrent VT/VF events were more common in patients randomized to receive fish oil (P<.001). CONCLUSION: Among patients with a recent episode of sustained ventricular arrhythmia and an ICD, fish oil supplementation does not reduce the risk of VT/VF and may be proarrhythmic in some patients.

Aged↗

Economic comparison of diagnostic approaches for evaluating osteoporosis in older women.

Of the technologies available, dual-energy X-ray absorptiometry of the hip or femoral neck (DXA-FN) is the best predictor of hip fractures. Diagnostic approaches utilizing measures of peripheral sites with office-based technology, such as calcaneal quantitative ultrasound (QUS), may reduce costs although clinical and economic outcomes have not been evaluated. The objective was to compare three approaches for diagnosing osteoporosis in older women. The design was a decision-analytic model using diagnostic measures and clinical and economic outcomes from the Study of Osteoporotic Fractures, a prospective cohort of older white women that measured BMD and QUS and assessed fracture outcomes. The setting and patients were a hypothetical cohort of older white women presenting for diagnosis of osteoporosis. For the diagnostic and treatment alternatives, three diagnostic approaches-DXA-FN alone, QUS alone and a sequential approach (first QUS, then DXA-FN for those with low values for QUS)-were compared to no diagnosis. The outcome measures were the number of women identified for treatment, number of hip fractures prevented following diagnosis and subsequent treatment, number of women needed to treat to prevent one hip fracture and total direct medical costs. The sequential approach identified fewer women to treat, prevented more hip fractures and incurred lower total costs than using DXA alone. Diagnosis with QUS alone identified more women to treat and incurred higher total costs than DXA alone under most conditions. Compared to other approaches for diagnosing osteoporosis, sequential use of QUS followed by DXA resulted in fewer women treated and lower total costs.

Absorptiometry, Photon↗

Bone marrow chemoprotection without compromise of chemotherapy efficacy in a rat brain tumor model.

Thiol chemoprotective agents can reduce chemotherapy side effects, but clinical use is limited due to concerns of impaired chemotherapeutic efficacy. We evaluated whether an optimized bone marrow chemoprotection regimen impaired the efficacy of enhanced chemotherapy against rat brain tumors. Nude rats with intracerebral human lung carcinoma xenografts were treated with carboplatin, melphalan, and etoposide phosphate delivered intra-arterially with osmotic blood-brain barrier disruption (n = 8/group). Thiol chemoprotection was N-acetyl-L-cysteine (1000 mg/kg) 60 min before chemotherapy and/or sodium thiosulfate (8 g/m(2)) 4 and 8 h after chemotherapy, when the blood-brain barrier is reestablished. Blood counts were obtained before treatment on day 3 and at sacrifice on day 9. N-acetylcysteine serum clearance half-life was 9 to 11 min. Pretreatment with N-acetylcysteine combined with delayed administration of sodium thiosulfate protected against toxicity toward total white cells, granulocytes, and platelets (P = 0.0016). Enhanced chemotherapy reduced intracerebral tumor volume to 4.3 +/- 1.0 mm(3) compared with 29.1 +/- 4.1 mm(3) in untreated animals (P < 0.0001). Tumor volume was 3.7 +/- 0.6 mm(3) in rats that received N-acetylcysteine before and sodium thiosulfate after chemotherapy. The data indicate the efficacy of enhanced chemotherapy for rat brain tumors was not affected by thiol chemoprotection that provided excellent protection for hematological toxicity. Negative interactions of thiols with antitumor efficacy were avoided by temporal and spatial separation of chemoprotectants and chemotherapy.

Acetylcysteine↗

Protection against cisplatin-induced ototoxicity by N-acetylcysteine in a rat model.

Cisplatin (CDDP) is a widely used chemotherapeutic agent that is highly ototoxic. Animal studies and clinical trials have shown that thiosulfates can protect against platinum-induced ototoxicity. This study investigated a new model for CDDP ototoxicity in the rat, and tested the potential chemoprotective effect of administering N-acetylcysteine (NAC) before giving CDDP. Long Evans rats were treated with CDDP 6 mg/kg delivered to the aorta via a retrograde right external carotid artery infusion, 15 min after intravenous (IV) infusion of saline (n=8) or NAC 400 mg/kg (n=8), such that the vertebral arteries were perfused. Subsequent groups were similarly treated with NAC 30 min before (n=7) and 4 h after (n=7) CDDP. Auditory brainstem response (ABR) thresholds were tested at 4-20 kHz, 7 days after treatment and compared to baseline ABR values. The NAC-treated rats exhibited no significant change from baseline values at all time intervals, while the saline-treated rats showed marked ototoxicity, especially at higher frequencies. Furthermore, the rats treated with NAC 15 min before CDDP exhibited less overall toxicity to CDDP, as evidenced in weight loss 7 days post-treatment (mean for saline=-39.63 g; mean for NAC=-21.13 g; p=0.0084). These data show that treatment with NAC can prevent CDDP-induced ototoxicity in rats.

Acetylcysteine↗

Current status and future of relapsed primary central nervous system lymphoma (PCNSL).

The treatment of primary central nervous system lymphoma (PCNSL) has centered around high-dose methotrexate and radiotherapy (RT). Methotrexate administered intra-arterially (IA) with blood-brain barrier disruption (BBBD) and without RT, has been a highly effective treatment with a 5 year survival of 42% without cognitive loss. The purpose of this analysis is to determine responses for patients with relapsed PCNSL treated with second line IA carboplatin-based chemotherapy with BBBD. Between February 1991 and April 2000, 37 relapsed PCNSL patients, most who failed front line therapy with methotrexate based chemotherapy, were treated at Oregon Health & Science University (OHSU) and Hadassah Hebrew University Hospital (HHUH) with IA carboplatin-based chemotherapy with BBBD. Nine patients had prior RT. The mean age was 57.5 years, and all but 1 patient were treated within 8 months after relapse. The median time for survival from first IA carboplatin/BBBD treatment was 6.8 months;however, 7 out of 37 patients survived > or = 27 months. Nine patients had radiographic complete response (CR), 4 patients had radiographic partial response (PR), 12 had stable disease (SD), 10 had progressive disease (PD), and 2 were non-evaluable. The median time to failure for patients with CR and PR was 9.1 months. One long-term survivor is alive at 91.0 months from first carboplatin/BBBD treatment. In conclusion, we show that relapsed PCNSL has shown sensitivity to second line IA carboplatin-based chemotherapy with BBBD. We have developed a new protocol using i.v. rituximab prior to BBBD with IA carboplatin, i.v. cyclophosphamide and i.v. etoposide phosphate. The long-term program goal is to consolidate dose-intensive chemotherapy with monoclonal antibody directed radiation. Because patients with recurrent PCNSL commonly continue to relapse even after obtaining a complete response to enhanced chemotherapy treatment, patients w ho complete or fail the above carboplatin/BBBD treatment regimen will be offered consolidation with radioimmunotherapy using zevalin (Ibritumomab tiuxetan), IDEC-2B8 conjugated with yttrium-90 (90Y).

Adult↗

Chemotherapeutic dose intensification for treatment of malignant brain tumors: recent developments and future directions.

Despite a large amount of research on malignant brain tumors over the past 70 years, the prognosis for most tumor types is poor. One current focus of research is increasing dose intensity of chemotherapeutic agents. Various ways to increase dose intensity include high-dose chemotherapy followed by stem cell rescue (eg, bone marrow transplant), blood-brain barrier disruption or use of RMP7 to increase transvascular drug delivery, local delivery of chemotherapeutic agents (convection enhancement or clysis, antibody conjugates, and biodegradable polymers), chemoprotective agents, and tumor sensitizers. Improved identification of patients likely to respond to a given regimen may also increase the effectiveness of chemotherapy. We also discuss approaches to improve the design of nonrandomized trials by identifying and controlling potential confounding variables. This will improve the quality of individual studies and perhaps the comparability across studies.

Antineoplastic Agents↗

Dose-response for chiropractic care of chronic low back pain.

BACKGROUND CONTEXT: There have been no trials of optimal chiropractic care in terms of number of office visits for spinal manipulation and other therapeutic modalities. PURPOSE: To conduct a pilot study to make preliminary identification of the effects of number of chiropractic treatment visits for manipulation with and without physical modalities (PM) on chronic low back pain and disability. STUDY DESIGN/SETTING: Randomized controlled trial with a balanced 4x2 factorial design. Conducted in the faculty practice of a chiropractic college outpatient clinic. PATIENT SAMPLE: Seventy-two patients with chronic, nonspecific low back pain of mechanical origin. MAIN OUTCOME MEASURES: Von Korff pain and disability (100-point) scales. METHODS: Patients were randomly allocated to visits (1, 2, 3 or 4 visits/week for 3 weeks) and to treatment regimen (spinal manipulation only or spinal manipulation with PM). All patients received high-velocity low-amplitude spinal manipulation. Half received one or two of the following PM at each visit: soft tissue therapy, hot packs, electrotherapy or ultrasound. RESULTS: Pain intensity: At 4 weeks, there was a substantial linear effect of visits favoring a larger number of visits: 5.7 points per 3 visits (SE=2.3, p=.014). There was no effect of treatment regimen. At 12 weeks, the data suggested the potential for a similar effect of visits on patients receiving both manipulation and PM. Functional disability: At 4 weeks, a visits effect was noted (p=.018); the slope for group means was approximately 5 points per 3 visits. There were no group differences at 12 weeks. CONCLUSIONS: There was a positive, clinically important effect of the number of chiropractic treatments for chronic low back pain on pain intensity and disability at 4 weeks. Relief was substantial for patients receiving care 3 to 4 times per week for 3 weeks.

Adult↗

The relationship of health care delivery system characteristics and legal factors to mode of delivery in women with prior cesarean section: a systematic review.

OBJECTIVE: To evaluate the relationship of health care delivery system characteristics and legal factors to mode of delivery in women with prior cesarean section. METHODS: We identified relevant studies by searching MEDLINE and HealthSTAR (1980 to May 2002), reference lists of pertinent articles, and recommendations of local and national experts. We also searched the online Cochrane systematic reviews and controlled trials registries, Database of Abstracts and Reviews on Effectiveness, and EMBASE databases. RESULTS: Studies of guidelines suggested that opinion leaders influence provider behavior regarding repeat cesarean delivery versus trial of labor decisions. Studies of hospital and insurance characteristics provided inconsistent results. There was insufficient evidence to evaluate the relationship between provider characteristics and delivery outcomes. Legislation and liability-related factors effected limited change. CONCLUSION: Studies of health care system characteristics and other factors focused primarily on rates of delivery modes (vaginal birth after cesarean or repeat cesarean delivery) rather than patient safety or health outcomes. Future studies must account for case mix, time trends, and other potential confounders, especially concerning associations of provider characteristics.

Cesarean Section, Repeat↗

Randomized, controlled, six-month trial of yoga in healthy seniors: effects on cognition and quality of life.

CONTEXT: There are potential benefits of mind-body techniques on cognitive function because the techniques involve an active attentional or mindfulness component, but this has not been fully explored. OBJECTIVE: To determine the effect of yoga on cognitive function, fatigue, mood, and quality of life in seniors. DESIGN: Randomized, controlled trial comparing yoga, exercise, and wait-list control groups. PARTICIPANTS: One hundred thirty-five generally healthy men and women aged 65-85 years. INTERVENTION: Participants were randomized to 6 months of Hatha yoga class, walking exercise class, or wait-list control. Subjects assigned to classes also were asked to practice at home. MAIN OUTCOME MEASURES: Outcome assessments performed at baseline and after the 6-month period included a battery of cognitive measures focused on attention and alertness, the primary outcome measures being performance on the Stroop Test and a quantitative electroencephalogram (EEG) measure of alertness; SF-36 health-related quality of life; Profile of Mood States; Multi-Dimensional Fatigue Inventory; and physical measures related to the interventions. RESULTS: One hundred thirty-five subjects were recruited and randomized. Seventeen subjects did not finish the 6-month intervention. There were no effects from either of the active interventions on any of the cognitive and alertness outcome measures. The yoga intervention produced improvements in physical measures (eg, timed 1-legged standing, forward flexibility) as well as a number of quality-of-life measures related to sense of well-being and energy and fatigue compared to controls. CONCLUSIONS: There were no relative improvements of cognitive function among healthy seniors in the yoga or exercise group compared to the wait-list control group. Those in the yoga group showed significant improvement in quality-of-life and physical measures compared to exercise and wait-list control groups.

Aged↗