DocumentsDate added
Original Research Article
Svensson, Travis K. RN, MD, PhD
Affiliation:
Associate Professor, School of Nursing and Health Professions, University of San Francisco
Adjunct Clinical Professor, Department of Family Medicine, Stanford University
Assistant Clinical Professor, Department of Psychiatry
University of California San Francisco
The name of the department(s) and institution(s) to which the work should be attributed:
School of Nursing and Health Professions, University of San Francisco
Department of Family Medicine, Stanford University
Department of Psychiatry
University of California San Francisco
Address reprint requests to
T. K. Svensson, MD, PhD
4104 24th Street #521
San Francisco, CA 94114 USA
1-415-424-4543 (Phone)
1-650-348-1515 (Fax)
Article citation:
Svensson TK. The Impact of operator education level on the safety and tolerability of transcranial magnetic stimulation. J Pharm Biomed Sci. 2015; 05(05):429-435. Available at www.jpbms.info
ABSTRACT:
The Food and Drug Administration (FDA) approved the NeuroStar Transcranial Magnetic Stimulation Therapy system for the treatment of major depressive disorder in the fall of 2008. Since that time more than 175 devices have been placed in both public and private practice settings. Transcranial Magnetic Stimulation (TMS) therapy requires psychiatric prescription and supervision, however there are no specific standards articulated by the FDA, the State Boards of Medicine or the State Boards of Nursing regarding TMS Operator qualification. Neuronetics, the manufacturer of the NeuroStar TMS Therapy systems holds that the device is so safe and well tolerated that anyone may be trained to be an effective and safe TMS Operator. Registered Nurse (RN)/Medical Doctor (MD) TMS Operators predominate in hospital, academic and institutional settings, whereas unlicensed allied health workers predominate in private practice settings. Using both quantitative and qualitative research methodologies, this study demonstrated the safety and tolerability of TMS therapy provided by non-RN/MD TMS Operators in our communities. This study suggests a role for a future prospective randomized controlled trial to demonstrate the efficacy of TMS provided by non-RN/MD TMS Operators.
KEYWORDS: Nursing; Food and Drug Administration; Transcranial Magnetic Stimulation (TMS) therapy.
Manuscript to be presented at the 11th Annual Cleveland Clinic Conference on Nursing Research, April 27-28, 2015.
REFERENCES
1.Demitrack, M. (2009, January 28). Discussion of TMS research trials. Philadelphia, PA. Discussion with Paul Boatman. (2010, January 28) (interviewed at Clinical Training & Research Institute). San Francisco, CA.
2.Janicak, P. G. (2010, May 26). Long-term durability of acute response to transcranial magnetic stimulation (TMS) in the treatment of pharmaco-resistant major depression. In New research poster session 7. July 1, 2000 conducted at the APA, APA, San Francisco, CA.
3.Gershon, A. A., Dannon, P. N., &Grunhaus, L. (2003, May 1). Transcranial magnetic stimulation in the treatment of depression [Psychiatry Online]. American Journal of Psychiatry, 160, Reviews and overviews. Retrieved July 19, 2010, from http://ajp.psychiatryonline.org/cgi/content/full/160/5/835.
4.McDonald, W. (2010, May 24). The clinical safety and efficacy of transcranial magnetic stimulation results from recent pivotal clinical trials. In Focal brain stimulation for psychiatric disorder: Clinical update. APA.
5.Aaronson, S. T. (2010, May 25). An open-label study of transcranial magnetic stimulation combined with antidepressant medication of the treatment of MDD. [Poster NR4-76]. In New research poster session 6. TMS Therapy Presentation at APA, APA, San Francisco, CA.
6.Demitrack, M. (2008, October 9). FDA clears NeuroStar TMS Therapy for the treatment of depression. Retrieved July 19, 2010, from Medical News Today: http://www.medicalnewstoday.com/articles/124958.php.
7.Neuronetics. (2008). (Neuroneticsneurostar TMS system user manual). Retrieved July 19, 2010, from FDA: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4273b1_15-NeuroStarUserManualRevision.pdf.
8.Hopkins WG. Research designs: choosing and fine-tuning a design for your study. Sportscience. 2008;12:12–21.
Source of funding: None
Competing interest / Conflict of interest: The author(s) have no competing interests for financial support, publication of this research, patents and royalties through this collaborative research. All authors were equally involved in discussed research work. There is no financial conflict with the subject matter discussed in the manuscript.
Disclaimer: Any views expressed in this paper are those of the authors and do not reflect the official policy or position of the Department of Defense.
Copyright © 2015 Svensson TK. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Research article
Adithi S Shetty1 , MS ,Harish Shetty2 , MD , Divya Hegde3 , MS, B. Suresh Kumar Shetty 4, MD , Jagadish Rao Padubidri 5,*, MD, Diplomate NB
Affiliation:
1Assistant Professor, Department of Obstetrics and Gynecology, Kasturba Medical College, Mangaluru (Affiliated to Manipal University), India.
2Professor and Head,Department of Obstetrics and Gynecology, K.S.Hegde Medical Academy, Mangaluru, India.
3Assistant Professor, Department of Obstetrics and Gynecology, A J Institute of Medical Sciences, Mangaluru, India.
4Professor, Department of Forensic Medicine and Toxicology, Kasturba Medical College, Mangaluru (Affiliated to Manipal University), India
5*Associate Professor, Department of Forensic Medicine and Toxicology, Kasturba Medical College, Mangaluru (Affiliated to Manipal University), India
The name of the department(s) and institution(s) to which the work should be attributed:
1. Department of Obstetrics and Gynecology, Kasturba Medical College, Mangaluru (Affiliated to Manipal University), India.
2.Department of Obstetrics and Gynecology, K.S.Hegde Medical Academy, Mangaluru, India.
3.Department of Obstetrics and Gynecology, A J Institute of Medical Sciences, Mangaluru, India.
4,5Department of Forensic Medicine and Toxicology, Kasturba Medical College, Mangaluru (Affiliated to Manipal University), India
Address reprint requests to
Dr. Jagadish Rao Padubidri.
Associate Professor, Department of Forensic Medicine and Toxicology, Kasturba Medical College, Light House Hill Road, Mangaluru (Affiliated to Manipal University), India or at ppjrao@gmail.com
Article citation: Shetty AS, Shetty H, Hegde D, Shetty BSK, Padubidri JR. Yolk sac abnormalities – Is it a reliable indicator of abortions? – A prospective study in the population residing in rural setup of Mangaluru, Karnataka, India. J Pharm Biomed Sci. 2015; 05(05):380-384. Available at www.jpbms.info
ABSTRACT: Objective: This study was undertaken to determine if there were different abortion rates between normal and abnormal yolk sacs between 5-10 weeks of gestation, its association with pregnancy outcome and correlation with other parameters
Materials and Methods: In this study, the yolk sac characteristics of 95 consecutive pregnant women, of 5-6.5 weeks gestation, with normal body mass index (BMI) were prospectively evaluated. All patients underwent two-dimensional transvaginal ultrasonography, which was performed by the same sonographer. We considered the following yolk sac characteristics as normal for classification: diameter: 2-5 mm; round shape; absence of degenerative changes. Yolk sacs that had diameters smaller than 2 mm or larger than 5 mm; a shape that was not round (i.e., oval or distorted); the presence of degenerative changes. The outcome is statistically analyzed.
Results: A total of 100 cases were evaluated. Five cases were excluded. 81(85.3%) continued beyond 20 weeks and the rest 14(14.7%) ended in abortions. About 95.7% of the pregnancies showed the presence of a yolk sac, while in 4.3% of them a yolk sac was absent. Pregnancies with large yolk sac diameter ended with abortions. The sensitivity of predicting normal outcome with regular yolk sac is as high as 94.2%, while specificity is 34.5%.
Conclusions: Abnormalities of the yolk sac size or shape, and absence can be used as a reliable indicators of early pregnancy.
KEYWORDS: Normal Yolk Sac; Abnormal Yolk Sac; Spontaneous Abortion; Transvaginal Ultrasound.
Statement of Originality of work: The manuscript has been read and approved by all the authors, the requirements for authorship have been met, and that each author believes that the manuscript represents honest and original work.
REFERENCES
1.Cepni I, Bese T, Os cal P, Budak E,IdiM,AksuMF, Significanceof yolk sac with vaginal sonography in the first trimester in the prediction of pregnancy outcome. Acta Obstetriciaet Gynacologca Scandenevia 1997; 76:969-972.
2.Lindsay DJ, Lovett IS, Lyons EA et al. Yolk sac diameter and shape at endovaginal US: predictors of pregnancy outcome in the first trimester. Radiology. 1992; 183:115-118.
3.Küçük T, Duru NK, Yenen MC, Dede M, Ergün A, Başer I. Yolk sac size and shape as predictors of poor pregnancy outcome. J Perinat Med. 1999; 27: 316-320.
4.Khaled S. Mousa, Amr Mohamed El- Helaly and Mahmoud Abd El-Aziz. The Value of Yolk Sac Diameter at Vaginal Ultrasonography as a Predictor of the First Trimester Pregnancy Outcome. Life Sci J. 2014; 11:236-240.
5.Tan S, Ipek A, Pektas MK, Arifoğlu M, Teber MA, Karaoğlanoğlu M. Irregular yolk sac shape: is it really associated with an increased risk of spontaneous abortion? J Ultrasound Med. 2011; 30:31-36.
6.Varelas FK, Prapas NM, Liang RI, Prapas IM, Makedos GA. Yolk sac size and embryonic heart rate as prognostic factors of first trimester pregnancy outcome. Eur J Obstet Gynecol Reprod Biol. 2008; 138:10-13.
7.Cho FN, Kan YY, Chen SN, Yang TL, Hsu PH. Very large yolk sac and bicornuate uterus in a live birth. J Chin Med Assoc. 2005; 68:535-537.
8.Tongsong T, Wanapirak C, Srisomboon J, Sirichotiyakul S, Polsrisuthikul T, Pongsatha S.Transvaginal ultrasound in threatened abortions with empty gestational sacs. Int J Gynaecol Obstet.1994; 46: 297-301.
9. Chama CM, Marupa JY, Obed JY. The value of the secondary yolk sac in predicting pregnancy outcome. J Obstet Gynaecol.2005; 25: 245-247.
10.Berdahl DM, Blaine J, Van Voorhis B, Dokras A. Detection of enlarged yolk sac on early ultrasound is associated with adverse pregnancy outcomes. Fertil Steril. 2010; 94: 1535-1537.
11.Malinowski W. Yolk sacs in twin pregnancy. Ginekol Pol. 2000; 71:815-818.
12.Błaszczyk K, Wojcieszyn M, Biernat M, Lukasik A, Wilk M, Poreba R. Predicting the risk of poor pregnancy outcome by ultrasound examination of yolk sac diameter. Ginekol Pol. 2000; 71: 699-703.
13.Nyberg DA, Mack LA, Laing FC, Patten RM. Distinguishing normal from abnormal gestational sac growth in early pregnancy. J Ultrasound Med 1987; 6:23-27.
14.Rowling SE, Coleman BG, Langer JE, Arger PH, Nisenbaum HL, Horii SC. First-trimester US parameters of failed pregnancy. Radiology. 1997; 203:211-217.
Source of funding: No Funding
Competing interest / Conflict of interest: The author(s) have no competing interests for financial support, publication of this research, patents and royalties through this collaborative research. All authors were equally involved in discussed research work. There is no financial conflict with the subject matter discussed in the manuscript.
Disclaimer: Any views expressed in this paper are those of the authors and do not reflect the official policy or position of the Department of Defense.
Copyright © 2015 Shetty AS, Shetty H, Hegde D, Shetty BSK, Padubidri JR. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.