Assessing 3D T2 FSE sequence for identification of the normal appendix: working toward a single-sequence MR appendicitis protocol.

PURPOSES: To assess the ability of a single isotropic 3D T2 FSE sequence to identify the normal appendix in children with potential implication as alternative second-line modality in pediatric appendicitis. MATERIALS AND METHODS: Retrospective review of MR abdomino-pelvis or pelvis in children from Oct 2014-Dec 2016 was done. Only exams with 3D T2 FSE sequence performed on a single scanner type were selected. Patients with history of post appendectomy, studies in which field of view did not include ileocecal valve, with technical and protocol errors, or with fat-saturated acquisition were excluded. All images were blindly reviewed by three radiologists. The following questions were asked: (1) Is the appendix visualized?, (2) What is the most clearly demonstrable plane?, (3) Where is the appendix located?, (4) Are there any findings indicating appendicitis? Average pairwise percentage and Fleiss Kappa were used to assess the inter-rater agreement on the visualization and location of the appendix. RESULTS: A total of 22 MRI studies were reviewed (F = 13:M = 9, Mean age = 11.45 yrs. [SD = 4.3]). Total MRI scan time was estimated at 6 mins. Readers saw appendix in 72.7-81.8%, and saw with high confidence in 12 cases (54.5%), low confidence in 4-6 case (18.2-27.3%), and did not see in 4-6 cases(18.2-27.3%). The average pairwise percentage agreement was 71.2%. Fleiss Kappa of overall rating of visualization was 0.52 (p < 0.001). Fleiss Kappa of high confidence of visualization was 0.76 (p < 0.001). Reader 1 and reader 2 saw the appendix best on the axial plane. Reader 3 saw the appendix best on the coronal plane. For location, deep pelvis was the most common identified location. The average pairwise percentage agreement was 68.2% and Fleiss Kappa was 0.76 (p < 0.001). There is no findings indicating appendicitis. CONCLUSION: A single 3D T2 FSE sequence had good ability to detect normal appendices and also allowed multiplanar reconstructions, which may use as a single-sequence protocol in cases of suspected appendicitis in children when ultrasound is inconclusive.

The research subject advocate at the University of Hawai'i Clinical Research Center: an added resource for protection of human subjects.

In early 2001 the National Institutes of Health (NIH) created the Research Subject Advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human subjects participating in clinical research studies. The purpose of this article is to describe the RSA position in the context of clinical research, with a particular emphasis upon the role of the RSA in one of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants. The RSA also conducts workshops, training and education sessions, and consultation with investigators to foster enhanced communication and adherence to ethical standards and safety regulations. Although it is too early to provide substantive evidence of positive outcomes, this article seeks to illuminate the value of the RSA position in ensuring that safety of research participants is accorded the highest priority at CRCs. Based upon initial results, we conclude that the RSA is an effective mechanism for achieving the NIH's goal of maintaining the utmost scrutiny of protocols involving human subjects.

The research subject advocate at minority Clinical Research Centers: an added resource for protection of human subjects.

In early 2001, the National Institutes of Health (NIH) created the research subject advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human participants in clinical research studies. We describe the RSA position in the context of clinical research, with a particular emphasis on the role of the RSA in two of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants. The RSA also conducts workshops, training and education sessions, and consultation with investigators to foster enhanced communication and adherence to ethical standards and safety regulations. Although we cannot yet provide substantive evidence of positive outcomes, this article illuminates the value of the RSA position in ensuring that safety of research participants is accorded the highest priority at CRCs. On the basis of initial results, we conclude that the RSA is an effective mechanism for achieving the NIH goal of maintaining the utmost scrutiny of protocols involving human subjects.