Myelographic Techniques for the Detection of Spinal CSF Leaks in Spontaneous Intracranial Hypotension.

OBJECTIVE: Spinal leakage of CSF causes almost all cases of spontaneous intracranial hypotension. Leak detection and localization are important for both diagnosis and treatment. The myelographic appearance of the leaks may vary, however, depending on the cause of the leak, rate of leakage, and imaging modality used. CONCLUSION: The purpose of this article is to review the imaging of spinal CSF leaks and to assist in the selection of appropriate imaging modalities in this condition.

Time-Dependent Changes in Dural Enhancement Associated With Spontaneous Intracranial Hypotension.

OBJECTIVE: The objective of our study was to determine whether the presence of individual imaging signs of spontaneous intracranial hypotension (SIH) is correlated with increasing duration of headache symptoms. Of particular interest is the relationship of symptom duration to dural enhancement because it is the most commonly identified imaging sign in patients with SIH. MATERIALS AND METHODS: Eighty-nine patients with SIH who underwent pretreatment brain MRI and total-spine CT myelography and whose medical record included data on the duration of clinical symptoms were included in this cross-sectional retrospective study. Brain imaging was reviewed for the presence of dural enhancement, brain sagging, and the "venous distention" sign. CT myelograms were assessed for CSF leak. If present, a leak was subcategorized as a high-flow or low-flow leak. Differences in headache duration between subjects with and those without individual imaging signs were compared. RESULTS: Subjects without dural enhancement on brain MRI had a longer average duration of symptoms than those with dural enhancement present (average symptom duration: 45.3 ± 59.0 [SD] vs 15.1 ± 33.0 weeks, respectively; p = 0.002). No difference in symptom duration was observed between subjects whose MRI studies showed and those whose MRI studies did not show brain sagging (p = 0.10) or the venous distention sign (p = 0.21). The presence of a CSF leak on CT myelography was not associated with symptom duration (p = 0.56) except in the subgroup of patients with low-flow leaks. CONCLUSION: Increasing symptom duration in SIH is associated with decreased prevalence of abnormal dural enhancement on brain MRI. Because dural enhancement is considered a hallmark imaging feature of this condition, its absence may exacerbate the problem of underdiagnosis in chronic cases of SIH.

MRI of the urethra in women with lower urinary tract symptoms: spectrum of findings at static and dynamic imaging.

OBJECTIVE: The purpose of our study was to determine the findings at both static and dynamic MRI in women with a clinically suspected urethral abnormality. MATERIALS AND METHODS: MRI of the urethra was performed in 84 women with lower urinary tract symptoms using multiplanar T2-weighted turbo spin-echo and unenhanced and contrast-enhanced gradient-echo sequences. A dynamic true fast imaging with steady-state free precession sequence was performed during straining in the sagittal plane. Images were evaluated by two radiologists for urethral pathology and pelvic organ prolapse. MRI findings were correlated with clinical symptoms using the Fisher's exact and Mann-Whitney tests. RESULTS: Urethral abnormalities were found in 10 of 84 patients (11.9%), including two urethral diverticula, five Skene's gland cysts or abscesses, and three periurethral cysts. Thirty-three patients (39.3%) were diagnosed with pelvic organ prolapse, of whom 29 (87.9%) were diagnosed exclusively on dynamic imaging. In 29 of 33 patients with prolapse (87.9%), the urethra was structurally normal. MRI showed 13 cystoceles and 17 cases of urethral hypermobility not detected on physical examination. Patients with a greater number of vaginal deliveries, stress urinary incontinence, frequency of voiding, and voiding difficulty were statistically more likely to have anterior compartment prolapse (p < 0.05). CONCLUSION: Including a dynamic sequence permits both structural and functional evaluation of the urethra, which may be of added value in women with lower urinary tract symptoms. Dynamic MRI allows detection of pelvic organ prolapse that may not be evident on conventional static sequences.

MRI of pelvic floor dysfunction: dynamic true fast imaging with steady-state precession versus HASTE.

OBJECTIVE: The objective of our study was to retrospectively compare the degree of pelvic organ prolapse shown on dynamic true fast imaging with steady-state precession (FISP) versus HASTE sequences in symptomatic patients. MATERIALS AND METHODS: Fifty-nine women (mean age, 57 years) with suspected pelvic floor dysfunction underwent MRI using both a sagittal true FISP sequence, acquired continuously during rest alternating with the Valsalva maneuver, and a sagittal HASTE sequence, acquired sequentially at rest and at maximal strain. Data sets were evaluated in random order by two radiologists in consensus using the pubococcygeal line (PCL) as a reference. Measurement of prolapse was based on a numeric grading system indicating severity as follows: no prolapse, 0; mild, 1; moderate, 2; or severe, 3. A comparison between sequences on a per-patient basis was performed using a Wilcoxon's analysis with p < 0.05 considered significant. RESULTS: Overall, 66.1% (39/59) of patients had more severe prolapse (>or= 1 degrees ) based on dynamic true FISP images, with 28.8% (17/59) of the cases of prolapse seen exclusively on true FISP images. Only 20.3% (12/59) of patients had greater degrees of prolapse on HASTE images than on true FISP images, with 10.2% (6/59) of the cases seen exclusively on HASTE images. A statistically significant increase in the severity of cystoceles (p < 0.01) and urethral hypermobility (p < 0.01)-with a trend toward more severe urethroceles (p < 0.07), vaginal prolapse (p < 0.09), and rectal descent (p < 0.06)-was shown on true FISP images. CONCLUSION: Overall, greater degrees of organ prolapse in all three compartments were found with a dynamic true FISP sequence compared with a sequential HASTE sequence. Near real-time continuous imaging with a dynamic true FISP sequence should be included in MR protocols to evaluate pelvic floor dysfunction in addition to dynamic multiplanar HASTE sequences.

Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review.

Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. The authors conducted a systematic review to determine the barriers to participation of underrepresented populations in cancer-related trials. Their search included English-language publications that reported original data on the recruitment of underrepresented groups to cancer treatment or prevention trials between 1966 and December 2005 in multiple electronic databases. They also hand-searched titles in 34 journals from January 2003 to December 2005 and they examined reference lists for eligible articles. Titles and abstracts were reviewed to identify relevant studies. Data on barriers to participation were synthesized both qualitatively and based on statistically significant associations with trial enrollment. Of 5257 studies that were cited, 65 studies were eligible for inclusion in the current analysis, including 46 studies on recruitment into cancer therapeutic trials, 15 studies on recruitment into prevention trials, and 4 studies on recruitment into both prevention and treatment trials. Numerous factors were reported as barriers to participation in cancer-related trials. However, only 20 of the studies reported statistically significant associations between hypothesized barriers and enrollment. The available evidence had limitations in quality regarding representativeness, justification of study methods, the reliability and validity of data-collection methods, potential for bias, and data analysis. The results indicated that underrepresented populations face numerous barriers to participation in cancer-related trials. The current systematic review highlighting the literature on recruitment of underrepresented populations to cancer trials and may be used as the evidence base toward developing an agenda for etiologic and intervention research to reduce the disparities in participation in cancer-related trials.

Applying justice in clinical trials for diverse populations.

BACKGROUND: Considerable attention has focused on increasing clinical trial participation for members of "underrepresented groups". However, doing so involves clarifying how to meet the demands of justice, or fairness, which provides the ethical mandate to enhance broad trial representation. PURPOSE: To examine the ethical principle of justice as it applies to recruiting diverse populations to clinical trials representation. METHODS: In this paper, we analyse the conceptual and practical challenges in applying the principle of justice to clinical trials representation. RESULTS: Different facets of justice include demands for both fair outcomes and fair processes. Including both of these facets in clinical trials policy should not only promote access to trials, but also help to provide a framework to improve fairness in representation in clinical trials. Efforts to evaluate recruitment of representation should include outcome and process measures. LIMITATIONS: The suggestions offered based on this conceptual analysis need to be tested empirically. CONCLUSIONS: Those involved in the design, conduct and oversight of clinical trials should consider all of the facets of justice when assessing representation in clinical trials and attempt to balance fair access to trials with a fair process that may require protection from being unduly pressured to participate.

Provider roles in the recruitment of underrepresented populations to cancer clinical trials.

BACKGROUND: Providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials because they often introduce the opportunity of clinical trials. The purpose of the current systematic review was to describe provider-related factors influencing recruitment of underrepresented populations to cancer clinical trials. METHODS: To find original studies on the recruitment of underrepresented populations to cancer clinical trials, electronic databases from January 1966 to December 2005 were searched; hand-searched titles in 34 journals from January 2003 to January 2006; and reference lists were examined of eligible articles. Title and abstract reviews were conducted to identify relevant studies. Potential articles were then abstracted using a structured instrument and a serial review process by 2 investigators. RESULTS: Eighteen studies were eligible for review: 13 targeted healthcare providers, 3 targeted patients/participants, and 2 targeted both providers and patients. The study designs included randomized controlled trial, concurrent controlled trial, case-control, descriptive, and qualitative. A lack of available protocols and/or a lack of provider awareness about clinical trials prevented providers from discussing the opportunity of clinical trials in 2 studies. In 14 studies, patient accrual was affected by provider attitudinal barriers relating to patient adherence to the study protocol, patient mistrust of research, patient costs, data collection costs, and/or patient eligibility. Providers' communication methods were barriers in 5 studies and promoters in 1 study. CONCLUSIONS: A heterogeneous body of evidence suggests that several provider-related factors influence recruitment of underrepresented groups to clinical trials. Future recruitment efforts should address these factors.

Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials.

BACKGROUND: Certain populations, including racial and ethnic minorities and older persons, have had a history of low participation in cancer-related trials, yet there has been little information reported on recruitment strategies tailored to improve their enrollment. METHODS: We conducted a systematic literature review to examine the methods used to study recruitment of underrepresented populations into cancer prevention and treatment trials and examined the studies that compared the efficacy and/or effectiveness of different recruitment strategies. We performed an electronic search through multiple databases including PubMed and a hand search of 34 journals. Potential studies were pulled and underwent title, abstract, and article review by at least two investigators. RESULTS: Fourteen articles examined recruitment of underrepresented populations into cancer trials and, of these, five compared efficacy or effectiveness of different strategies for recruitment of underrepresented populations into randomized or concurrent controlled trials. These five studies used various strategies but only three reported that specific recruitment strategies, such as media campaigns and church-based project sessions, resulted in improvement in accrual to cancer trials. CONCLUSION: There is limited evidence for efficacious or effective strategies to recruit underrepresented populations in cancer-related trials. The available evidence cannot be generalized to these heterogeneous groups. Further study is needed on efficacious strategies for recruitment of underrepresented populations into cancer-related trials.