Off-label use of intravascular iodinated organic and MR contrast media.

UNLABELLED: This paper analyses off-label prescribing of the iodinated organic and magnetic resonance (MR) contrast media used in diagnostic imaging and evaluates the liability profiles and medicolegal issues associated with such use. The term off-label generally indicates the use of known drugs for which new scientific evidence suggests use in a manner and in clinical scenarios not explicitly addressed by the drug data sheet and is outside the indications for which the medication was approved. In addition, the term also indicates the use of drugs with a different route of administration and dosage from those indicated in the information leaflet. Intravascular contrast media used in diagnostic imaging are drugs in the complete sense of the term, even though they have unique characteristics which in many ways distinguish them from other pharmacological agents. The off-label use of contrast media in diagnostic imaging is a little-investigated field and most commonly, but not exclusively, applies to gadolinium-based contrast media used in MR angiography as well as cardiac and paediatric applications. In particular, the off-label use of contrast media mostly concerns deviations from the recommended dose. As contrast media are to all effects pharmaceutical agents, their off-label use can be considered admissible within the limitations laid down by the Italian law in force (Article 3 of Law 94/98) and its interpretation, i.e. the following criteria must be present: the lack of a valid diagnostic alternative; written informed consent by the patient; the presence of scientific publications validated at the international level; assumption of responsibility by the radiologist. CONCLUSIONS: The use of contrast media in modern image-guided medicine is essential. In cases in which the information contained in the information leaflet is modified and updated in any way whatsoever (indications, dosage, at others), specifically if restrictions are introduced in accordance with the law in force, the pharmaceutical industry must provide formal and timely notification to radiologists. On their part as prescribers and users of contrast media, radiologists must remain up to date regarding any changes in indications, dosage and route of administration. Lastly, we propose that the radiology report includes not only the type but also the dose of contrast medium used.

The evolving role of MRI in oncohaematological disorders.

Magnetic resonance imaging (MRI) has opened new possibilities to current diagnostic radiology in the evaluation of bone marrow. Compared with other imaging modalities, MRI is the only technique able to directly visualise bone marrow with its different components of red and yellow marrow. Other advantages of MRI are high-contrast resolution and multiplanar view, as well as extensive coverage of the skeleton with whole-body MRI (WBMRI). However, specificity of signal alterations of bone marrow is low. Therefore, MRI findings need to be integrated with clinical and laboratory findings as well as with haematological and oncological evaluation. MRI provides information that effectively aids diagnosis, staging and follow-up of various bone marrow disorders. There is increasing interest in the capabilities of MRI in the evaluation of bone marrow, in particular of haematological malignancies. According to some authors much work remains to be done to improve sensitivity and specificity of MRI in order to define the real clinical value of this imaging modality in the multidisciplinary management of patients with a haematological malignancy. This article presents recent developments and perspectives in the use of MRI in oncohaematological diseases.

[The value of the MR imaging in the evaluation of Müllerian duct anomalies]. / Il valore della RM nella valutazione delle anomalie dei dotti di Müller.

PURPOSE: To reaffirm the role of MRI in the assessment of the M#159;llerian duct anomalies (MDAs). MATERIAL AND METHODS: Between November 1997 and April 2001, 22 patients, age range 18-40 years (mean 29 years) were investigated with MRI and US. The MRI study was performed with a 0,5 Tesla imager (Vectra, GE Medical System) with body-coil; neither oral nor intravenous contrast was used. We obtained SE T1-weighted, fast STIR with fat suppression and FSE T2-weighted sequences. Sagittal, paracoronal and paraxial images were acquired. The paraxial images were obtained to produce true coronal images of the uterus. In evaluating MDAs, imaging the uterus in its true coronal plane is essential to assess the external fundal contour. US examination was performed with an HDI 3000, ATL, using the trans-vaginal approach. The MDAs were subdivided according to the Buttram and Gibbons classification. RESULTS: There were 22 cases of laparoscopic and hysteroscopic proved anomalies; MRI allowed correct diagnosis of 21 uterine anomalies (accuracy, 95%) whereas U.S. was correct in 20 of 22 cases (accuracy, 92%). The MRI was excellent in depicting the uterine morphology in one case of unicornuate uterus with rudimentary horn non-comunicating with the main cavity and distended by hematometra and associated hematosalpinx. Further-more evaluating composition, thickness and extension of the uterine septum and aspect of the fundal contour, MRI allowed to differentiate definitively between bicornuate uterus and septate uterus. This is a very important distinction to do because it significantly affects patient treatment: a septate uterus requires hysteroscopic septectomy, while a bicornuate uterus does not requires surgical treatment. CONCLUSIONS: Given its characteristics, MRI is a very accurate imaging modality in uterine evaluation and contributes significantly to treatment planning. Although ultrasonography remains the modality of choice for the initial study of patients who are suspected of having a MDAs, we propose, in accordance with many authors in the literature, to reserve MRI imaging for patients with a technically inadequate or indeterminate ultrasound examination.

Course of illness following specialized inpatient treatment for women with trauma-related psychopathology.

The authors report findings from repeated assessments of 101 women who received intensive inpatient treatment focused on trauma-related disorders. All patients were assessed at admission and discharge, and half were reassessed at 1-year follow-up. Measures included the Global Assessment Scale, Brief Psychiatric Rating Scale, Brief Symptom Inventory, Role Functioning Scales, Follow-up Adjustment Scale, and Client Satisfaction Questionnaire. As a group, patients improved substantially during hospitalization and maintained gains at follow-up, although they showed a trend toward relapse in some symptom areas. However, a substantial minority of patients continued to show severe impairment at follow-up. In light of continual need for changes in clinical programs in the face of declining reimbursement, there is a pressing need for future outcome research on specialized trauma programs to relate subsequent clinical course to specific treatment interventions.

Dissociative detachment and memory impairment: reversible amnesia or encoding failure?

The authors propose that clinicians endeavor to differentiate between reversible and irreversible memory failures in patients with dissociative symptoms who report "memory gaps" and "lost time." The classic dissociative disorders, such as dissociative amnesia and dissociative identity disorder, entail reversible memory failures associated with encoding experience in altered states. The authors propose another realm of memory failures associated with severe dissociative detachment that may preclude the level of encoding of ongoing experience needed to support durable autobiographical memories. They describe how dissociative detachment may be intertwined with neurobiological factors that impair memory, and they spell out the significance of distinguishing reversible and irreversible memory impairment for diagnosis, patient education, psychotherapy, and research.

[The role of magnetic resonance in the diagnosis of the os trigonum syndrome]. / Il ruolo della Risonanza Magnetica nella diagnosi della sindrome dell'os trigonum.

PURPOSE: We investigated the yield of Magnetic Resonance Imaging (MRI) in hindfoot conditions, particularly the os trigonum syndrome, which are very difficult to diagnose clinically. MATERIAL AND METHODS: We examined 7 consecutive patients complaining of hindfoot pain for more than 4 months (male:female = 1:6; age range 16-22 years, average 18.6). Three patients practiced competitive sports and 4 ballet. We performed conventional radiography (orthogonal projections) and then MRI with a 0.5 T superconductive unit with surface coils; MR images were acquired with T1-weighted spin-echo (SE), T2-weighted gradient-echo (GRE), and fast inversion recovery (FIR) fat-suppressed sequences with 4 mm thickness and 0 mm gap. RESULTS: In 2 cases the os trigonum had irregular margins with subchondral sclerosis and widened synchondrosis. In 3 patients we found flexor hallucis longus tenosynovitis, likely caused by tendon compression and displacement within its sheath; there were neither os trigonum marrow edema nor synchondrosis widening. One patient had os trigonum hypertrophy, mild synchondrosis widening and marrow edema, in the os trigonum and the posterior aspect of talus. One patient had the os trigonum, but no signs referable to the os trigonum syndrome. CONCLUSIONS: In the posterior impingement syndrome, our objective is to show inflammatory changes in the posterior capsule of the ankle joint, adjacent ligaments, tendons and chondrosynovial surface. In these cases, the yield of conventional radiography and CT is rather poor, while MRI provides important information on soft tissues involvement, synovial reaction, chondral and subchondral bone injuries and the association of flexor hallucis longus synovitis, if present. MRI also yields detailed information for correct therapeutic approach. In conclusion, for the (differential) diagnosis of hindfoot pain in clinically suspected os trigonum syndrome, MRI appears to be the technique of choice, after conventional radiography, thanks to its noninvasiveness, multiplanarity, and high spatial and contrast resolution.

Dissociative detachment relates to psychotic symptoms and personality decompensation.

Previous studies have addressed the prominence of psychotic symptoms in conjunction with multiple personality disorder (now dissociative identity disorder). The present study examines the relation between psychotic symptoms and a more pervasive form of dissociative disturbance, namely dissociative detachment. Two hundred sixty-six women in inpatient treatment for severe trauma-related disorders completed the Dissociative Experiences Scale (DES), and 102 of these patients also completed the Millon Clinical Multiaxial Inventory (MCMI-III). A factor analysis of the DES yielded two dimensions of dissociative detachment: detachment from one's own actions and detachment from the self and the environment. Each of these DES dimensions relates strongly to the thought disorder and schizotypal personality disorder scales of the MCMI-III. We propose that severe dissociative detachment, by virtue of loosening the moorings in inner and outer reality, is conducive to psychotic symptoms and personality decompensation.