Comparación de una secuencia en 3D con eco de gradiente potenciada en T1 con 3 factores de reducción de imagen en paralelo diferentes, en apnea y respiración libre, utilizando una bobina de 32 canales a 1,5T. Estudio preliminar / A comparison of a T1 weighted 3D gradient-echo sequence with three different parallel imaging reduction factors, breath hold and free breathing, using a 32 channel coil at 1.5T. A preliminary study

Objetivo. Analizar si el aumento de la resolución temporal utilizando mayores factores de reducción (FR) de imagen en paralelo (IP), tanto en apnea como con respiración libre, utilizando una secuencia 3D con eco de gradiente (EG) potenciada en T1, sin contraste y una bobina de múltiples elementos (phased array) de 32 canales, proporciona una calidad de imagen diagnóstica, con posibilidad de ser aplicada en pacientes que no puedan cooperar para mantener la apnea. Material y métodos. Se incluyeron en el estudio 9 sujetos sanos (5 mujeres y 4 varones; rango de edad: 20-49; media: 36 años). Se les realizó un estudio de RM abdominal con secuencias 3D EG en un equipo de 1,5T con bobina de múltiples elementos (phased-array) de 32 canales con FR de imagen en paralelo de 2, 4 y 6, en apnea y con respiración libre. Dos revisores evaluaron retrospectiva y cualitativamente la calidad de imagen de las secuencias, la magnitud de los artefactos, incluyendo los artefactos de movimiento por reducción de señales, de solapamiento (aliasing), de granulado de los píxeles y la heterogeneidad de la señal. Los resultados se compararon mediante la prueba de Wilcoxon de los rangos con signo y la corrección de Bonferroni para comparaciones múltiples. Resultados. La adquisición en apnea proporcionó mejor calidad de imagen y menos artefactos que la adquisición con respiración libre. La tasa de artefactos fue mayor para FR más altos. La mejor calidad se obtuvo con secuencias en apnea con un FR = 2. Un FR = 4 presentó tasas menores pero diagnósticas (p = 0,004). La severidad de los artefactos, en especial el granulado de los píxeles (p = 0,004), hizo que las secuencias con un FR = 6 no fueran diagnósticas. Ninguna de las secuencias obtenidas con respiración libre fue diagnóstica. Conclusión. Las secuencias obtenidas en apnea con un FR = 2 presentaron una calidad de imagen excelente, y aquellas con un FR = 4 presentaron una calidad buena y potencialmente se pueden aplicar en pacientes poco colaboradores. Ninguna de las secuencias obtenidas con respiración libre se consideró diagnóstica (AU)

Purpose. To investigate whether increasing temporal resolution with higher parallel imaging (PI) reduction factors (RF) in both breath-hold and free breathing approaches, using a non-contrast T1-weighted 3D gradient echo (GRE) sequence and a 32-channel phased array coil, permits diagnostic image quality, with potential application in patients unable to cooperate with breath-hold requirements. Materials and methods. The 9 healthy subjects (5 females and 4 males; age range was 20-49, mean 36 yrs) were recruited. A 3D GRE MR imaging of the abdomen was performed on 1.5T MR system using a 32-element phased-array torso coil with PI RFs of 2, 4 and 6, breath hold and free breathing. Two reviewers retrospectively qualitatively evaluated all sequences for image quality, extent of artifacts, including motion, truncation, aliasing, pixel graininess and signal heterogeneity. The results were compared using Wilcoxon signed rank and a Bonferroni adjustment was applied for multiple comparisons. Results. Image quality and extent of artifacts were better with breath hold than with free breathing acquisitions. The rate of artifacts increased with higher RF. The best quality was acquired with breath hold sequence using RF=2. RF=4 had lower but diagnostic rates (P=.004). The severity of artifacts, mainly pixel graininess (P=.004), rendered sequences with RF=6 non-diagnostic. All sequences were non-diagnostic in free breathing acquisitions. Conclusion. Breath hold sequences with RF=2 had excellent quality and RF=4 had good quality and may be potentially used in partially cooperative patients. None of the sequences was considered diagnostic in free breathing acquisitions (AU)

A comparison of a T1 weighted 3D gradient-echo sequence with three different parallel imaging reduction factors, breath hold and free breathing, using a 32 channel coil at 1.5 T. A preliminary study.

PURPOSE: To investigate whether increasing temporal resolution with higher parallel imaging (PI) reduction factors (RF) in both breath-hold and free breathing approaches, using a non-contrast T1-weighted 3D gradient echo (GRE) sequence and a 32-channel phased array coil, permits diagnostic image quality, with potential application in patients unable to cooperate with breath-hold requirements. MATERIALS AND METHODS: The 9 healthy subjects (5 females and 4 males; age range was 20-49, mean 36 yrs) were recruited. A 3D GRE MR imaging of the abdomen was performed on 1.5 T MR system using a 32-element phased-array torso coil with PI RFs of 2, 4 and 6, breath hold and free breathing. Two reviewers retrospectively qualitatively evaluated all sequences for image quality, extent of artifacts, including motion, truncation, aliasing, pixel graininess and signal heterogeneity. The results were compared using Wilcoxon signed rank and a Bonferroni adjustment was applied for multiple comparisons. RESULTS: Image quality and extent of artifacts were better with breath hold than with free breathing acquisitions. The rate of artifacts increased with higher RF. The best quality was acquired with breath hold sequence using RF=2. RF=4 had lower but diagnostic rates (P=.004). The severity of artifacts, mainly pixel graininess (P=.004), rendered sequences with RF=6 non-diagnostic. All sequences were non-diagnostic in free breathing acquisitions. CONCLUSION: Breath hold sequences with RF=2 had excellent quality and RF=4 had good quality and may be potentially used in partially cooperative patients. None of the sequences was considered diagnostic in free breathing acquisitions.

The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims.

The importance of appropriately and effectively incorporating the patient's voice into the evaluation of new medical products has been recognized and affirmed by regulators.(1,2,3) Patient-reported outcomes (PROs) are increasingly being assessed in clinical trials to quantify treatment benefits such as symptom relief and improved functioning. Translating PRO-based treatment benefits into labeling claims can provide information to physicians and patients and assist in prescribing decisions.(4,5) Hence, standardizing the valid and reliable measurement of PRO end points is critical.

The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.

Patient-reported outcome (PRO) measures provide an important perspective on how patients feel and function that cannot be adequately captured by clinical measures. A PRO is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient's response by a clinician or anyone else.

Psychoactive medication prescribing practices for U.S. children: gaps between research and clinical practice.

OBJECTIVE: To determine national pediatric prescribing practices for psychotropic agents and to examine these practices in view of the available evidence concerning their safety and efficacy in this age group. METHOD: Prescribing data from 2 national databases based on surveys of office-based medical practices were determined and reviewed vis-à-vis available safety and efficacy evidence. RESULTS: Data indicate that levels of psychotropic prescribing in children and adolescents are greatest for stimulants, resulting in nearly 2 million office visits and 6 million drug "mentions" in 1995. Selective serotonin reuptake inhibitors were the second most prescribed psychotropic agents, while anticonvulsant mood stabilizers (prescribed for a psychiatric reason), tricyclic antidepressants, central adrenergic agonists, antipsychotics, benzodiazepines, and lithium were also prescribed for a substantial number of office visits. Comparison of prescribing frequencies with available safety and efficacy data indicates significant gaps in knowledge for commonly used agents. CONCLUSIONS: Most psychotropic agents require further sustained study to ensure appropriate health care expenditures and vouchsafe children's safety. Recommendations for researchers, parents, federal agencies, and industry are offered as a means to accelerate the pace of research progress.

Symptomatic cardiotoxicity associated with 5-fluorouracil.

A prospective cohort study was conducted in 35 hospitals with oncology units to determine the incidence of symptomatic cardiotoxicity in patients receiving continuous infusions of 5-fluorouracil (5-FU), and to identify risk factors that could contribute to the development of 5-FU-associated cardiotoxicity. A sample of 483 patients [197 (41%) women, overall average age +/- SD 60.9 +/- 11.9 yrs] were followed for one cycle of 5-FU infusion. Thirty-eight (7.9%) patients had abrupt termination of the infusion. There were 9 (1.9%) cases of suspected or documented cardiotoxic events. Cardiotoxicity occurred in 7 (3.35%) of 209 patients receiving their first course of 5-FU and in 2 (0.73%) other patients (p=0.044). Based on univariate analysis, the following patient groups were at elevated risk of cardiotoxicity: those with preexisting cardiac disease (RR=6.83, p=0.0023); patients receiving calcium channel blockers (RR=4.75, p=0.014); those receiving nitrates (RR=9.18, p=0.007); and patients receiving concomitant etoposide (RR=10.32, p=0.022). Patients with underlying cardiac disease require close monitoring while receiving continuous infusions of 5-FU. They should be observed for signs and symptoms of cardiotoxicity, and vital signs should be measured frequently. Continued reporting of 5-FU-associated cardiotoxicity is necessary to identify other patients at risk.

Need for uniform data elements in hospital drug use review.

The need of a nationwide system of drug use review (DUR) in hospitals is discussed. Many drugs important in terms of both potential adverse effects and cost (e.g., aminoglycosides and heparin) are used primarily in hospitals, a setting for which nationwide data on key elements of use and prescribing are not available. A main problem is one of logistics, stemming primarily from a lack of uniformity in how drug information is recorded. Since data collection and organization are pivotal prerequisites for drug use review, there is a need for standardization in data collection if data from various institutions are to be compared. Uniform data elements are proposed that would allow for national tabulations and estimates, which could provide the normative data critical to both drug use review and drug epidemiology.

Low cost, manual drug use review of Medicaid recipients to screen prescriber and pharmacist performance.

A manual drug use review (DUR) methodology to screen outpatient prescribing which would meet the needs of large third-party programs that cannot afford elaborate computerized DUR was developed and pilot tested. A Medicaid drugs data base was used for the pilot test. A probability sample of 100 recipients over a three-month period was selected for the DUR. The drugs for each recipient, listed by their generic composition and amount, were recorded. Then a priori, explicit, screening criteria were developed for these generics. These criteria delineated drugs of choice, daily dose and refill patterns and, as appropriate, therapy length, drug holidays, and disease-drug and drug-drug interactions. Only 11% of recipients had prescribing patterns which passed all the screens. The most frequent screening failure was due to the prescribing of a drug which was not a drug of choice. In nearly all of the cases which failed the other screens, an alert pharmacist with patient records should have noticed these problems. An analysis showed that the initial start-up cost for the manual DUR was estimated at $1053 (not including personnel fringe benefits); for subsequent quarterly review, the cost was estimated to be about $530. The project showed that manual DUR can effectively and efficiently screen prescribing in a large third-party program.