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71.
Najat C Daw Wayne L Furman Clinton F Stewart Lisa C Iacono Mark Krailo Mark L Bernstein Janet E Dancey Rose Anne Speights Susan M Blaney James M Croop Gregory H Reaman Peter C Adamson 《Journal of clinical oncology》2005,23(25):6172-6180
PURPOSE: Epidermal growth factor receptor is expressed in pediatric malignant solid tumors. We conducted a phase I trial of gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, in children with refractory solid tumors. PATIENTS AND METHODS: Gefitinib (150, 300, 400, or 500 mg/m2) was administered orally to cohorts of three to six patients once daily continuously until disease progression or significant toxicity. Pharmacokinetic studies were performed during course one (day 1 through 28). RESULTS: Of the 25 enrolled patients, 19 (median age, 15 years) were fully evaluable for toxicity and received 54 courses. Dose-limiting toxicity was rash in two patients treated with 500 mg/m2 and elevated ALT and AST in one patient treated with 400 mg/m2. The maximum-tolerated dose was 400 mg/m2/d. The most frequent non-dose-limiting toxicities were grade 1 or 2 dry skin, anemia, diarrhea, nausea, and vomiting. One patient with Ewing's sarcoma had a partial response. Disease stabilized for 8 to > or = 60 weeks in two patients with Wilms' tumor and two with brainstem glioma (one exophytic). At 400 mg/m2, the median peak gefitinib plasma concentration was 2.2 microg/mL (range, 1.2 to 3.6 microg/mL) and occurred at a median of 2.3 hours (range, 2.0 to 8.3 hours) after drug administration. The median apparent clearance and median half-life were 14.8 L/h/m2 (range, 3.8 to 24.8 L/h/m2) and 11.7 hours (range, 5.6 to 22.8 hours), respectively. Gefitinib systemic exposures were comparable with those associated with antitumor activity in adults. CONCLUSION: Oral gefitinib is well tolerated in children. Development of the drug in combination with cytotoxic chemotherapy will be pursued. 相似文献
72.
73.
Understanding the minimum clinically important difference: a review of concepts and methods. 总被引:2,自引:0,他引:2
Anne G Copay Brian R Subach Steven D Glassman David W Polly Thomas C Schuler 《The spine journal》2007,7(5):541-546
BACKGROUND CONTEXT: The effectiveness of spinal surgery as a treatment option is currently evaluated through the assessment of patient-reported outcomes (PROs). The minimum clinically important difference (MCID) represents the smallest improvement considered worthwhile by a patient. The concept of an MCID is offered as the new standard for determining effectiveness of a given treatment and describing patient satisfaction in reference to that treatment. PURPOSE: Our goal is to review the various definitions of MCID and the methods available to determine MCID. STUDY DESIGN: The primary means of determining the MCID for a specific treatment are divided into anchor-based and distribution-based methods. Each method is further subdivided and examined in detail. METHODS: The overall limitations of the MCID concept are first identified. The basic assumptions, statistical biases, and shortcomings of each method are examined in detail. RESULTS: Each method of determining the MCID has specific shortcomings. Three general limitations in the accurate determination of an MCID have been identified: the multiplicity of MCID determinations, the loss of the patient's perspective, and the relationship between pretreatment baseline and posttreatment change scores. CONCLUSIONS: An ideal means of determining the MCID for a given intervention is yet to be determined. It is possible to develop a useful method provided that the assumptions and methodology are initially declared. Our efforts toward the establishment of a MCID will rely on the establishment of specific external criteria based on the symptoms of the patient and treatment intervention being evaluated. 相似文献
74.
Acta Endoscopica - C’est un test de sélection. C’est un outil important de communication et d’information, c’est dire si elle doit être connue, comprise et bien... 相似文献
75.
76.
Donna K. McNeese-Smith Mary E. Wickman Marie Earvolino-Ramirez Mel Moncrieff Scott Robertson 《Journal of addictions nursing》2006,17(2):105-113
This article reports the results of semi-structured interviews with substance abuse treatment (SAT) program directors (PDs) regarding the ways SAT is being influenced by managed care (MC), plans for future SAT, and strategies for decreasing costs of care. It compares findings to an earlier survey of 50 SAT PDs.
Interviews were conducted in 20 SAT programs to gather information about treatment delivery since the advent of MC, including PD responsibilities, funding source, treatment intensity, location, duration, and methods of treatment. Open-ended responses were used to gather information about current and future plans in providing SAT, and awareness of new types of treatment being planned by organizations impacted by MC.
PDs reported changes in SAT secondary to MC such as decreased treatment length, limiting of inpatient and outpatient services, and delayed treatment secondary to benefit determination. Political and economic constraints were seen as barriers to providing adequate and effective services. SAT being subsumed by mental health was viewed as problematic along with an emerging split between alcohol abuse and drug treatment. A positive emerging treatment trend was the development of targeted programs for special need groups.
PDs revealed a variety of strategies that have promoted necessary adaptations to economic and political influences within the structure of managed behavioral care. Strategies such as varying treatment length, modality, and subspecialty care reflected necessary adaptations to diverse market needs.
Managed care continues to have a tremendous impact on the delivery of SAT services. While MC has helped to contain costs, negative outcomes are decreased availability of appropriate care and overtaxing of units that have survived MC cut backs. However, special need programs have allowed SAT programs to specialize, expand, and even flourish in today's competitive SAT market. Interviews with PDs reinforced the need for maintaining quality and diversified SAT services in today's MC environment. 相似文献
Interviews were conducted in 20 SAT programs to gather information about treatment delivery since the advent of MC, including PD responsibilities, funding source, treatment intensity, location, duration, and methods of treatment. Open-ended responses were used to gather information about current and future plans in providing SAT, and awareness of new types of treatment being planned by organizations impacted by MC.
PDs reported changes in SAT secondary to MC such as decreased treatment length, limiting of inpatient and outpatient services, and delayed treatment secondary to benefit determination. Political and economic constraints were seen as barriers to providing adequate and effective services. SAT being subsumed by mental health was viewed as problematic along with an emerging split between alcohol abuse and drug treatment. A positive emerging treatment trend was the development of targeted programs for special need groups.
PDs revealed a variety of strategies that have promoted necessary adaptations to economic and political influences within the structure of managed behavioral care. Strategies such as varying treatment length, modality, and subspecialty care reflected necessary adaptations to diverse market needs.
Managed care continues to have a tremendous impact on the delivery of SAT services. While MC has helped to contain costs, negative outcomes are decreased availability of appropriate care and overtaxing of units that have survived MC cut backs. However, special need programs have allowed SAT programs to specialize, expand, and even flourish in today's competitive SAT market. Interviews with PDs reinforced the need for maintaining quality and diversified SAT services in today's MC environment. 相似文献
77.
Isabelle Mermet MD ; Nathalie Pottier MSc ; Jean Marie Sainthillier MSc ; Carole Malugani MSc ; Sandrive Cairey-Remonnay MD ; Stéphane Maddens PhD ; Didier Riethmuller MD PhD ; Pierre Tiberghien MD PhD ; Philippe Humbert MD PhD ; François Aubin MD PhD 《Wound repair and regeneration》2007,15(4):459-464
Amniotic membrane (AM), the most internal placental membrane, has unique properties including antiadhesive effects, bacteriostatic, wound protection and pain-reduction properties, as well as epithelialization initialization capacities. Furthermore, AM is widely available and less costly than other bioengineered skin substitutes. In a prospective pilot study, we evaluated the safety, feasibility, and the effects on healing of AM graft in 15 patients with chronic venous leg ulcers. AM grafts were prepared from placentas harvested during cesarean section. All grafted AM had adhered to the wound bed 7 days after being applied with a 100% engraftment rate. The percentage of granulation tissue increased significantly (from 17% on day 0 to 69% on day 14, p<0.0001), along with a significant decrease of fibrinous slough (from 36% at day 0 to 16% at day 14, p<0.001). A significant clinical response occurred in 12 patients (80%) including complete healing (20%) in three during the 3-month follow-up period. The ulcer surface area decreased significantly from a mean value (+/- standard deviation) of 4.59 +/- 2.49 cm(2) at baseline to 2.91+/-2.01 cm(2) on day 30 (p<0.001). All patients experienced a significant reduction of ulcer-related pain rapidly after AM transplantation. No adverse events were recorded. AM transplantation seems to function as a safe substrate, promoting proper epithelialization while suppressing excessive fibrosis. Further advantages of biotherapy with AM are its easy and low-cost production, and that it can be applied as an ambulatory treatment without immobilization. AM transplantation may thus be considered to be an alternative method for treating chronic leg ulcers. 相似文献
78.
Annie Mathieu Stéphanie Mazza Dominique Petit Anne Décary Jessica Massicotte-Marquez Jacques Malo Jacques Montplaisir 《Clinical neurophysiology》2007,118(7):1538-1544
OBJECTIVE: The aim of this study was to determine whether EEG slowing is more pronounced in older than younger OSAS patients and to verify whether this cortical slowing is correlated to daytime performance, respiratory perturbation and sleep fragmentation. METHODS: Twelve young OSAS patients (mean age 38.2+/-2.0 y) and 13 older OSAS patients (mean age 62.2+/-1.9 y) along with 13 young controls (mean age 35.8+/-2.0 y) and 14 older controls (mean age 60.2+/-2.0 y) underwent a polysomnographic evaluation followed by a waking EEG recording. As a global index of cortical slowing, a ratio of slow-to-fast frequencies was calculated in all cortical regions. Daytime performance was assessed using the four choice reaction time test. RESULTS: Differences in waking EEG and in daytime performance were analyzed by ANOVAs with Group and Age as factors. Waking EEG did not yield a Group by Age interaction. OSAS patients had higher ratios across all regions than controls. Similarly, daytime performance revealed no Group by Age interaction. However, OSAS patients showed more lapses than controls and older subjects were slower than younger subjects. CONCLUSIONS: Our results indicate that age does not interact with OSAS to worsen the severity of cortical slowing, but age can add to the OSAS effect to worsen daytime performance deficits in OSAS patients. SIGNIFICANCE: The daytime performance deficits observed particularly in elderly OSAS patients warrant a careful clinical assessment of these patients to prevent accidents and injuries. 相似文献
79.
Sylvia J T Jansen Wilma Otten Anne M Stiggelbout 《Journal of clinical oncology》2004,22(15):3181-3190
PURPOSE: Many studies have determined cancer patients' preferences for adjuvant therapy, for example, by asking patients the extent of benefit they would need in order to accept the therapy. However, little is known about the determinants that influence these preferences. Our research goal was to explore which determinants underlie patients' preferences by means of a literature review. METHODS: PubMed searches were conducted to identify studies in which cancer patients' preferences for adjuvant therapy had been elicited by means of a treatment preference instrument. Twenty-three papers were evaluated with regard to reported relationships between preferences and potential determinants. A total of 40 determinants were recorded and classified into one of seven categories: (1) treatment-related determinants, (2) sociodemographic characteristics and current quality of life, (3) clinical characteristics, (4) measurement instrument-related determinants, (5) time-related determinants, (6) cognitive/affective determinants, and (7) specialist-related determinants. Results: The benefit and toxicity of treatment, experience of the treatment, and having dependents (eg, children) living at home were important determinants of patients' preferences. Furthermore, qualitative data suggested that cognitive/affective and specialist-related determinants might have a large impact on patients' treatment preferences. CONCLUSION: Our results show that patients' preferences cannot fully be explained on the basis of treatment-related determinants and patient and clinical characteristics. More research is needed in the area of cognitive/affective and specialist-related determinants because of the lack of quantitative results. Furthermore, we recommend carrying out larger studies in which the (internal) relationships between determinants and preferences are assessed in the context of a cognitive cost-benefit model. 相似文献
80.
Anne?Helene?Garde ?se?Marie?Hansen Johnni?Hansen 《International archives of occupational and environmental health》2009,82(10):1219-1228