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Biomedical subjects

T Vollmer

Publications and source records attributed to T Vollmer.

16 recordsLinked to original sources

Does multiple sclerosis-associated disability differ between races?

OBJECTIVE: To investigate differences in disability between African American and Caucasian patients with multiple sclerosis (MS) by comparing the relationship between current age and disability between races and by assessing the effect of adjustment for socioeconomic status (SES) on the associations. METHODS: The authors selected US participants from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry with an age at symptom onset of 10 to 60 years, who reported their race as Caucasian or African American (n = 21,557). They classified participants as having mild, moderate, or severe disability in the domains of mobility, hand function, cognition, and vision using Patient Determined Disease Steps and Performance Scales and assessed the association of disability with race using polytomous logistic regression. RESULTS: Disability increased more rapidly with increasing disease duration in older patients, but there was no interaction between race and age. African Americans had increased odds of severe vs mild disability in all four domains (odds ratio [OR] [95% CI]: hand 1.35 [1.10 to 1.64]; vision 1.75 [1.37 to 2.27]; cognition 1.32 [1.04 to 1.67]; mobility 1.32 [1.11 to 1.56]). Adjustment for all covariates, including SES, attenuated these associations (OR [95% CI]: hand 1.27 [1.00 to 1.61]; vision 1.59 [1.19 to 2.08]; cognition 0.98 [0.74 to 1.30]; mobility 1.37 [1.11 to 1.67]). Lack of adjustment for SES produced stronger associations. After enrollment in NARCOMS, disability progression did not differ between the groups. CONCLUSIONS: African Americans experience greater multiple sclerosis-associated disability than Caucasians. Failure to account for socioeconomic status leads to overestimation of these differences. Disease progression is similar in African Americans and Caucasians after diagnosis.

Adolescent↗

[Evaluation of a structured outpatient education program for adult asthmatics].

BACKGROUND AND OBJECTIVE: In this study the effectiveness of an outpatient education program for adult asthmatics (AFAS) was evaluated in a controlled and randomized trial over a period of 6 months. PATIENTS AND METHODS: In a randomized controlled study 78 educated patients with mild to moderate asthma (mean age 48.6 years) and 42 equally treated but "sham-trained" patients (control group; mean age 48.3 years) were compared after 6 months. The average duration of the disease was 16.7 years. Main items of the eight-hour outpatient education program were the peak-flow-controlled self-medication of the patients, the correct use of the medication, as well as information about the disease and its treatment. The patients of the control group underwent a "sham-training" (short education about inhalation technique and use of peak-flow meter). RESULTS: The knowledge about the disease, measured by a multiple-choice-test including 27 items, increased in the intervention group from initially 28.9+/-2 % to 90.0+/-3.6 % (p < 0.001). After AFAS 87.5 % of patients were able to manage their asthma attacks by themselves (initially 26.2 %; p = 0.009). Inhaled glucocorticoids were used more regularly (p = 0.037), the percentage of patients with mild and severe asthma attacks during the last weak decreased significantly (p < 0.001). The SF-12 life quality score increased significantly (p < 0.001). The control group revealed no significant differences in all these parameters. CONCLUSION: Judged by the reduction of morbidity and an optimization of the medication as well as a higher quality of life, AFAS under outpatient conditions appears to be an efficient and cost-effective method of modern asthma management.

Administration, Inhalation↗

Changes in the ascertainment of multiple sclerosis.

OBJECTIVE: With diagnostic criteria alterations, increased MRI availability, and awareness of therapies, temporal changes in incidence and prevalence rates may occur, with an increase in the proportion of mildly affected persons diagnosed with multiple sclerosis (MS). The authors assessed temporal trends in the delay from symptom onset to diagnosis (DONDX), and determined whether the degree of disability at diagnosis differs by year of symptom onset (YONSET), using the NARCOMS Registry. METHODS: The authors selected US participants with an age at symptom onset of 10 to 60 years, and YONSET > or = 1980 (n = 16,581). The authors divided YONSET into 5-year groups and compared DONDX between groups using multivariate Cox regression. The authors classified participants enrolled within 2 years of diagnosis (n = 5,548) as having mild, moderate, or severe disability using Patient Determined Disease Steps, and assessed the association of disability with YONSET using polytomous logistic regression. RESULTS: DONDX decreased with later YONSET (r = -0.43, p < 0.0001). This association remained after adjustment for demographic factors in a multivariate Cox model. Later YONSET was associated with increased odds of having mild disability at diagnosis as compared to severe disability (OR = 1.10 per year; 1.09 to 1.11). CONCLUSION: The delay from symptom onset to diagnosis is steadily decreasing in MS. An increasing proportion of patients with MS have mild disability at diagnosis after accounting for confounders. As the effectiveness of therapies is influenced by disease duration, this has implications for comparison of treatment effects in modern clinical trials to earlier study results.

Adolescent↗

Fibreoptic tracheal intubation after placement of the laryngeal tube.

BACKGROUND: The laryngeal tube is a new alternative for securing the airway. After adequate oxygenation, insertion of a tracheal tube is still required in many situations. In such circumstances, fibreoptic placement of a tube exchange catheter after placement of the laryngeal tube is possible before tracheal intubation. Throughout the procedure, oxygen administration can continue via the laryngeal tube, the tube exchange catheter and the tracheal tube. METHODS: The feasibility of this technique was tested in 10 patients scheduled for elective surgery. RESULTS: The laryngeal tube was placed at the first attempt with adequate ventilation in all patients. The tube exchange manoeuvre was performed successfully in all but one patient. CONCLUSION: This technique is an important alternative for airway management and provides a significant degree of patient safety.

Aged↗

Predictors of adherence to Copaxone therapy in individuals with relapsing-remitting multiple sclerosis.

The purpose of this study was to evaluate psychological, biophysical, and sociodemographic variables as predictors of adherence to glatiramer acetate (Copaxone) therapy in individuals with relapsing-remitting multiple sclerosis (MS). Because Copaxone is a daily subcutaneous injection, individuals with MS are challenged by the daily routine of preparation and administration of this medication. Despite the challenges, some individuals with MS adhere to treatment with injectable medications with little or no difficulty, while others struggle to adhere to, and soon abandon, the daily task. It is important to identify predictors of adherence to Copaxone therapy so those at risk can be identified early and provided with individualized support at the onset of therapy. Potential participants were identified from the Consortium of Multiple Sclerosis Centers North American Research Committee on Multiple Sclerosis Patient Registry database (n = 600) and from the Shared Solutions MS patient support database (n = 600). Individuals who had taken or stopped taking Copaxone were specifically selected. Those taking multiple immunomodulating drugs or not able to complete the data collection instruments were excluded. Booklets containing four instruments (MS Self-Efficacy Control and Function Subscales, Rosenberg Self-Esteem Scale, Herth Hope Index [HHI], and Performance Scale) and sociodemographic data sheets were mailed to 1,200 individuals. Of the 594 who completed and returned booklets, 341 individuals had relapsing-remitting MS and met the inclusion criteria. There were 225 individuals in the adherent group and 116 in the nonadherent group. Logistic regression analysis revealed four significant predictors of adherence: self-efficacy (control), hope, perception that the doctor was the most supportive of the individual taking Copaxone, and no previous use of other immunomodulators. The higher the score on the MS Self-Efficacy Control Subscale and HHI, the more likely the individual will adhere to Copaxone therapy. The MS Self-Efficacy Control Subscale and HHI show promise of being useful predictors of adherence. Further testing is recommended. Physician support should be conveyed to all individuals starting and maintaining Copaxone therapy for MS. Greater support needs to be provided to those who have previously taken immunomodulating drugs.

Adult↗

Reliability and validity of two self-report measures of impairment and disability for MS. North American Research Consortium on Multiple Sclerosis Outcomes Study Group.

OBJECTIVE: To describe the results of a multicenter study that validated two new patient-reported measures of neurologic impairment and disability for use in MS clinical research. BACKGROUND: Self-reported data can provide a cost-effective means to assess patient functioning, and can be useful for screening patients who require additional evaluation. METHODS: Thirteen MS centers from the United States and Canada implemented a cross-sectional validation study of two new measures of neurologic function. The Symptom Inventory is a measure of neurologic impairment with six subscales designed to correlate with localization of brain lesion. The Performance Scales measure disability in eight domains of function: mobility, hand function, vision, fatigue, cognition, bladder/bowel, sensory, and spasticity. Measures given for comparison included a neurologic examination (Expanded Disability Status Scale, Ambulation Index, Disease Steps) as well as the patient-reported Health Status Questionnaire and the Quality of Well-being Index. Participants included 274 MS patients and 296 healthy control subjects who were matched to patients on age, gender, and education. RESULTS: Both the Symptom Inventory and the Performance Scales showed high test-retest and internal consistency reliability. Correlational analyses supported the construct validity of both measures. Discriminant function analysis reduced the Symptom Inventory to 29 items without sacrificing reliability and increased its discriminant validity. The Performance Scales explained more variance in clinical outcomes and global quality of life than the Symptom Inventory, and there was some evidence that the two measures complemented each other in predicting Quality of Well-being Index scores. CONCLUSIONS: The Symptom Inventory and the Performance Scales are reliable and valid measures.

Adult↗

Extended use of glatiramer acetate (Copaxone) is well tolerated and maintains its clinical effect on multiple sclerosis relapse rate and degree of disability. Copolymer 1 Multiple Sclerosis Study Group.

When 251 relapsing-remitting patients with multiple sclerosis were randomized to receive daily subcutaneous injections of glatiramer acetate, previously called copolymer 1 (Copaxone; n = 125) or placebo (n = 126) for 24 months, there were no laboratory abnormalities associated with glatiramer acetate treatment and it was well tolerated with few side effects. Patients receiving glatiramer acetate had significantly fewer relapses and were more likely to be neurologically improved, whereas those receiving placebo were more likely to worsen. This study was extended for 1 to 11 months (mean of 5.2 months for the glatiramer acetate group and 5.9 months for the placebo group). The blinding and study conditions used during the core 24-month study were unchanged throughout the extension. The results of this extension study confirm the excellent tolerance and safety profile of glatiramer acetate for injection. The clinical benefit of glatiramer acetate for both the relapse rate and for neurologic disability was sustained at the end of the extension trial.

Adult↗

Relationship of the antispasticity effect of tizanidine to plasma concentration in patients with multiple sclerosis.

BACKGROUND: Spasticity is a serious problem in multiple sclerosis (MS) and many patients do not achieve a satisfactory response to currently available oral antispasticity drugs. Tizanidine hydrochloride, an alpha 2-noradrenergic agonist, has been shown to have an antispasticity effect in single center trials of patients with MS. OBJECTIVE: To compare plasma concentrations of tizanidine with objective measures of muscle tone in patients with MS with moderate to severe spasticity. SETTING: Ten centers, all tertiary referral centers for the specialized treatment of patients with MS, in the United States and Canada. DESIGN: A randomized, double-blind, placebo-controlled, dose-response study of tizanidine hydrochloride (8 or 16 mg). PATIENTS: One hundred forty-two patients with spastic MS who were not taking any interfering medication, such as an antispasticity drug or other alpha-noradrenergic agonist, entered the trial. RESULTS: Tizanidine treatment reduced muscle tone significantly, as shown by improved Ashworth scores and increased knee swing amplitude recorded by the pendulum test, both of which correlated significantly with plasma concentration. Placebo had no significant effect on muscle tone. Dizziness, drowsiness, dry mouth, and fatigue were reported most often in the group treated with tizanidine at peak plasma concentration. CONCLUSIONS: Tizanidine reduces spasticity in MS, and both therapeutic effects and side effects are related to the plasma drug levels.

Adrenergic alpha-Agonists↗

The quality-of-life effects of interferon beta-1b in multiple sclerosis. An extended Q-TWiST analysis.

BACKGROUND: A recombinant form of interferon beta-1b (Betaseron) was given Food and Drug Administration approval for use in the treatment of relapsing-remitting multiple sclerosis in 1993 based on a documented reduction in exacerbation rate. However, its effect on disease progression is less clear. It costs $11,000 per year and has documented adverse effects such as fatigue, feverlike symptoms, and depression. OBJECTIVES: To evaluate a recombinant form of interferon beta-1b in the treatment of relapsing-remitting multiple sclerosis and to discuss treatment trade-offs and comprehensive quality-of-life (QOL) outcomes. METHODS: We present a randomized evaluation of treatment with a recombinant form of interferon beta-1b in 79 patients with multiple sclerosis who participated in a random allocation lottery and were followed up for 12 months, during which data on QOL and clinical outcomes were collected. The data were analyzed using the Extended Quality-Adjusted Time Without Symptoms and Toxicity (Q-TWiST) method, which evaluates treatment trade-offs by incorporating several QOL domains and patient preferences regarding these domains. RESULTS: Over the 12 months of follow-up, the case patients reported 10.6 months of quality-adjusted time, while the control patients reported 10.4 months of quality-adjusted time (P = .50). CONCLUSIONS: Thus, the first year of treatment with interferon beta-1b did not significantly improve or detract from QOL. Results are discussed in terms of acceptable trade-offs depending on the nature of therapy. Future observational and clinical studies should incorporate measures of patient preference.

Adjuvants, Immunologic↗

Unilateral transplantation of human fetal mesencephalic tissue into the caudate nucleus of patients with Parkinson's disease.

BACKGROUND: Parkinson's disease is characterized by the loss of midbrain dopamine neurons that innervate the caudate and the putamen. Studies in animals suggest that fetal dopaminergic neurons can survive transplantation and restore neurologic function. This report compares the clinical results in four case patients with severe Parkinson's disease who underwent stereotaxic implantation of human fetal ventral mesencephalic tissue in one caudate nucleus with the results in a control group of similar subjects assigned at random to a one-year delay in surgery. METHODS: Each case patient received cryopreserved tissue from one fetal cadaver (gestational age, 7 to 11 weeks). Before implantation, adjacent midbrain tissue underwent microbiologic, biochemical, and viability testing. Cyclosporine was administered for six months postoperatively. RESULTS: The procedure was well tolerated. Three case patients showed bilateral improvement on motor tasks, as assessed on videotape, and were more functional in the activities of daily living, as assessed by themselves and neurologists, during both optimal drug therapy and "drug holiday" periods. One case patient, who died after four months from continued disease progression, had striatonigral degeneration at autopsy. In the patients who received transplants, optimal control was achieved with a lower dose of antiparkinsonian medications, whereas the controls required more medication. Positron-emission tomography with [18F]fluorodopa before and after surgery in one patient revealed a bilateral restoration of caudate dopamine synthesis to the range of normal controls, but continued bilateral deficits in the putamen. CONCLUSIONS: Although the case patients continued to be disabled by their disease, unilateral intracaudate grafts of fetal tissue containing dopamine diminished the symptoms and signs of parkinsonism during 18 months of evaluation.

Activities of Daily Living↗