Review Request Research Articles

Awareness Comparison in Career Decision-Making Self-Efficacy of University Students with and without Disabilities

The purpose of this study was to compare the career decision-making self-efficacy of university students with and without disabilities and to examine the characteristics of the career decision-making self-efficacy of students with disabilities by analyzing the differences in their background variables and subscales. The study participants were 30 university students with disabilities who attend J university, which has a disabled student support center, and 60 university students without disabilities. Their self-efficacy was measured by the Career Decision-Making Self-Efficacy Scale–Short Form, which consists of five subscales. The results form this study are as follow: First, the results of a comparison of the factors of the career decision self-efficacy of university students with and without disabilities indicated that students without a disability had higher levels of information gathering than those with a disability, and that there was no difference in the levels by academic field. Second, a comparison of the factors representing background variables indicated that physical science and engineering university students with disabilities showed more meaningful differences than arts and social science students in the following areas, ordered from greatest to least difference: accurate self-appraisal, problem solving, and making plans for the future. Students in the Received(August 06, 2014), Review request(August 07, 2014), Review Result(1st: August 22, 2014) Accepted(December 10, 2014) Publish(December 31, 2014) 560-759 Dept. Secondary Special Education, Jeonju Univ., 303 Cheonjam-ro, Wansan-gu, Jeonju, Korea email: leeoug@jj.ac.kr Awareness Comparison in Career Decision-Making Self-Efficacy of University Students with and without Disabilities Copyright c 2014 SERSC 314 upper grade had higher levels than those in the lower grade, and students with in grades 4-5 had the highest level of factors like target selection, information gathering, and problem solving.

A Feature Extraction Method Using Empirical Mode Decomposition and Histogram Modeling for Robust Bearing Fault Diagnosis

This paper proposes a method using empirical mode decomposition (EMD) and histogram modeling for bearing defects of a low-speed rotational induction motor. The proposed method minimizes signal distortion caused by noise using the EMD and conducts histogram envelope modeling by normalizing a signal. Then, the method extracts and selects unique features of each fault using partial autocorrelation coefficients (PARCOR) and distance evaluation technique (DET). Using the extracted features as inputs, support vector Received(July 10, 2014), Review request(July 11, 2014), Review Result(1st: July 24, 2014) Accepted(December 10, 2014) Publish(December 31, 2014) 689-749 School of Electrical Engineering, University of Ulsan, Nam-gu, Ulsan, Korea. email: fahmid.farid@gmail.com 689-749 School of Electrical Engineering, University of Ulsan, Nam-gu, Ulsan, Korea. email: nasha0339@gmail.com (Corresponding Author) 689-749 School of Electrical Engineering, University of Ulsan, Nam-gu, Ulsan, Korea. email: jmkim07@ulsan.ac.kr * This research was supported by Basic Science Research Program through the National Research Foundation of Korea(NRF) funded by the Ministry of Education, Science and Technology(NRF-2012R1A1A2043644) A Feature Extraction Method Using Empirical Mode Decomposition and Histogram Modeling for Robust Bearing Fault Diagnosis Copyright c 2014 SERSC 282 regression (SVR) classifies inner, outer, and roller faults of a bearing. For the optimal classification performance, we vary a variable of the kernel function of SVR ranging from 0.01 to 1.0 and the number of features ranging from 2 to 250. Experimental results indicate that the proposed method having a parameter of 0.55 and 45 features outperforms conventional fault classification methods, yielding an average of 95% classification performance.

Comparison of Korean and Japanese Elementary School Students' Achievement on Inquiry-based Science Assessment Items

This study looked at Korean elementary school students' performance in inquiry-based science by subjecting Korean sixth graders to Japanese national standard science assessment items. The purpose of this study was to assess the Korean science curricula and to compare the two groups' level of inquiry. Also this study not only compared the science achievement of Korean and Japanese students, but it also Received(June 24, 2014), Review request(June 25, 2014), Review Result(1st: July 07, 2014) Accepted(December 10, 2014) Publish(December 31, 2014) 660-759 Dept. Science Education, Chinju National University of Eduction, Shinan-dong, Jinju, Gyeongnam, Korea email: ytkong@cue.ac.kr * This work was supported by the National Research Foundation of Korea Grant funded by the Korean Government (NRF-2013R1A1A2004851). Comparison of Korean and Japanese elementary school students' achievement on inquiry-based science assessment items Copyright c 2014 SERSC 202 compared the two nations' assessment of academic achievement in science. The results are as follows: (1) Science curricula in both Korea and Japan stress the importance of inquisition; moreover, Japanese science curriculum tends more to emphasize scientific-inquiry aptitude that is progressively connected within in grade level hierarchy. (2) Much like their science curricula, the two nations' assessment both stress importance of retention and conceptualization of inquiry-based science to strengthen future competence. (3) Students' inquiry-based science capabilities were evaluated by contrasting at the accuracy rates of responses across different types of items. (4) Both Korean and Japanese students had a difficulty for applying and describing the concepts and terminology used in science. Students of both nations also had problems organizing and assessing experimental results. This study has implications for managements in both Korean national-standard study achievement and the recent science education curriculum.

Antidepressant-like Effects of Berchemia Berchemiaefolia via NFkB Signal Transduction in Rat Models of Depression

Berchemia berchemiaefolia(BB) is a genus of plants in the family Rhamnaceae. Traditionally BB has been already used for liver defender in Korea. But the study about antidepressant-like activity and related molecular mechanisms of BB were not studied well. The effects of subacute treatment with BB(86 and 285 mg/kg, p.o.) on immobility and FST-induced changes of immune parameters were investigated by using the forced swimming test (FST) in rats. As a result, BB immobility decreases with a dose-dependency in the FST. The levels of cortisol, IL-6, IL-1β, and TNF-α of treatment group were significantly decreased than those of the FST group. Similarly p-p65 and p-65 activity of treatment group were decreased than those of the FST group. In all, these results indicate that BB extract can be a very effective treatment for Received(August 13, 2014), Review request(August 14, 2014), Review Result(1st: August 27, 2014, 2nd: November 06, 2014) Accepted(December 10, 2014) Publish(December 31, 2014) 614-714 Dept. Physics, Dong-Eui University, 176 Eomgwangno, Busanjin-gu, Busan, Korea. email : bmjin@deu.ac.kr 614-714 Dept. Clinical Laboratory Science, Dong-Eui University, 176 Eomgwangno, Busanjin-gu, Busan, Korea. email : rokmagnum@naver.com (Corresponding Author) 614-714 Dept. Clinical Laboratory Science, Dong-Eui University, 176 Eomgwangno, Busanjin-gu, Busan, Korea. email : kyhyun@deu.ac.kr * 이 논문은 동의대학교 연구과제(2014AA170)에 의해 수행되었습니다. Antidepressant-like effects of Berchemia berchemiaefolia via NFkB signal transduction in rat models of depression Copyright c 2014 SERSC 80 depression, suggesting that the down-regulation of NFkB activity is related to Antidepressant Effect of Berchemia berchemiaefolia.

A Practicum Training Model for Early Childhood Pre-Service Teacher Using UML

Recently, there is important outstanding infant teachers to improve the quality of the early childhood education. Therefore, we require to have effective infant education knowledge for teachers and to reinforce practicum training program that can experience education field. However, practicum training programs are operated by different level of the condition and the environment of each institute and organization until now. It is because there is perfunctory program operations of early childhood education, a lack of Received(September 11, 2014), Review request(September 12, 2014), Review Result(1st: September 25, 2014, October 13, 2014) Accepted(December 10, 2014) Publish(December 31, 2014) 690-756 Dept. of Education, Graduate School of Education, Jeju National Univ., 102 Jejudaehakro, Jejusi, Jeju Province. email: edu114@jejunu.ac.kr (Corresponding Author) 690-756 Dept. of Computer Engineering, College of Engineering, Jeju National Univ., 102 Jejudaehakro, Jejusi, Jeju Province email: kimdh@jejunu.ac.k 690-756 Dept. of Education, Graduate School, Jeju National Univ., 102 Jejudaehakro, Jejusi, Jeju Province email: jhusuk@hanmail.net 440-711 Dept. Gyeonggi Do Provincial Institute for lifelong Learning, 1150, Gyeongu-daero, Jangan-gu, Suwon city, Gyeonggi-do Province. email: eunhyun@gill.or.kr * “이 논문은 2014학년도 제주대학교 학술진흥연구비 지원사업에 의하여 연구되었음” A Practicum Training Model for Early Childhood Pre-Service Teacher Using UML Copyright c 2014 SERSC 224 cooperation system between universities and field organization, and unclear standards of teaching practice contents and methods. In this paper, we propose a practicum training model for early childhood pre-service teacher using UML(Unified Modeling Language) to visualize standardized cooperation methods, forms, steps and communications of the parties. It is possible to support to clarify the cooperation methods, operation procedures, operation contents in infant education trainees’ point of view by this model. And we can give help to understand infant teaching practice processes, procedures and contents easily in the parties’ point of view.

Levels of occupational stress and stressful activities for nurses working in emergency

The study aimed to identify stress levels, areas and their activities identified as stressful by nurses working in the emergence in Manaus, AM, Brazil. It is an epidemiological, cross-sectional design, with 36 emergency nurses from December 2010 to January 2011. The Bianchi Stress Scale with 57 questions was used. The nurses were at risk for high levels of stress. The most stressful areas were the operation of the unit, conditions of work and personnel administration, and the most stressful activity was the request for equipment review and repair. The difference by Friedman test between the areas was significant (p <0.05), Dunn post-test significant (p <0.05) when compared by peers. The accumulation of management activities with the assistance activities can generate higher levels of stress, it is necessary to invest in improving the work environment and management support to minimize the stress experienced at work.

Quality is our lifeblood.

Quality is our lifeblood.

Considering Statistical Logic in Otology

Objectives: Illustrate strong and weak statistical concepts used in otolaryngologic papers submitted for publication regardless of acceptance. Methods: For 1 calendar year, the type and number of statistical concerns were recorded for 56 otologic papers submitted for publication to 1 of 5 journals. Results: Ninety-nine concerns were found in 32 of the 56 papers. Reviewers identified several concerns in many papers. For some papers, data reanalysis was possible with different statistical tests, but in none was the conclusion altered. A summary of the findings with some overlap of the categories follows. Conclusions not supported by data – 13. Confusion of correlation with causation – 13. “Fishing trip” – 12. Overgeneralization – 9. Multiple t tests for related outcomes – 8. Multiple tests - inappropriate tests – 8. Parametric tests were used but underlying assumptions clearly violated – 7. Conclusion inappropriate or absent – 7. Lack of required power analysis – 4. Inappropriate assignment to groups when assessing group differences – 3. Partial data analysis – 3. Reviewer requests power analysis when not needed – 2. Reviewer requests inappropriate tests - 2. Conclusions: Application of statistics in otology papers was surprisingly good. The most common flaws in statistical interpretation in submitted papers were (1) that the conclusion reported was not supported by the data or (2) confusion between association and causation. Even if statistics were applied inappropriately, thoughtful reviewers were generally able to detect errors in statistical logic even if they did not feel that they were qualified as statisticians.

How to Write a Paper Hall George M How to Write a Paper 5th edition 157pp £24.99 Wiley-Blackwell/BMJ Books 9780470672204 047067220X

I WAS delighted when this slim, handbag-sized, lightweight paperback reference book, with easy reading font, arrived on my desk with a request for review.

The obstacles facing scientific and medical publishing in Saudi Arabia.

BACKGROUND AND OBJECTIVESMedical and scientific publishing in Saudi Arabia has flourished in the last ten years. Such a form of publishing faces its own obstacles and the experience of the Annals of Saudi Medicine if analyzed can delineate such obstacles. The aim of this study is to identify the workflow obstacles facing the Annals of Saudi Medicine.METHODSRoot-cause analysis of the workflow process and output from submission till publication for the period January 2012–December 2013. Key performance indicators were developed and analyzed after being extracted from the online submission system.RESULTSFor the period of the study, 1058 manuscripts were received annually. These manuscripts originated in descending order from: Saudi Arabia 34%, Turkey 16%, India 12%, China 8% and Western Countries 3%. Categories of the submissions were: original articles 53%, case reports 31% and others 16%. Only 103 of the submissions were accepted annually for publication. Out of 7,709 requests to review a manuscript, only 1,579 (20%) resulted in a review. Out of a sample of 744 rated reviews, only 10% were poor in quality. The average turnaround time for review was 79 days. The main reason for the delay was the low response of the reviewers.CONCLUSIONThe Annals of Saudi Medicine is a regional or continental journal with substantial submissions as case reports. This affected its Impact Factor and Hirsch Index. Moreover, the review process is delayed due to the poor response of the reviewers.

Defusion of labor disputes in China: collective negotiations, mediation, arbitration, and the courts

This paper addresses the uses of the arbitration and judicial processes in the resolution of individual and collective labor rights arising under contract or statute. These labor rights are in contrast to labor interests of yet-unsecured rights, such as wage increases. An interesting phenomenon occurred wherein the rapid rise in the arbitration cases following the 2008 Mediation and Arbitration Law has slowed whereas the number of court cases rose and then leveled off, though continuing at that higher level. Analysis is made whether this increase from administrative relief to judicial relief was a temporary aberration and whether judicial appeals may undermine the arbitration process. Also addressed is whether existing legislation would be improved by letting arbitration be the final remedy, absent illegalities. This paper first provides a larger context of “labor disputes” and how they “diffuse” in different ways, some illegal and more volatile than others, including, strikes (plant sit-ins), collective bargaining, etc. Secondly, the devices of mediation and arbitration are briefly introduced as methods of regulating and “defusing” labor rights disputes. The next section explores the actual uses of arbitration and the courts in the resolution of labor disputes and notes the continued use of the courts notwithstanding the high percentage of worker-friendly decisions in mediation and arbitration. Analysis is made whether the government’s new 2010 and 2011 policies of further promoting consultation, mediation, and arbitration of labor disputes will have an effect on requests for judicial review which fluctuated upwardly since 2008 or whether the policies need further adjustment to accord more finality to arbitration decisions.

Let us have some consideration for the lowly reviewer

Published 2014. This article is a U.S. Governmen and is in the public domain in the USA. Scientific publishing represents a three-component collaborative process consisting of the author(s), the journal (editor), and the technical reviewer(s). In terms of the benefits received, the process should be analogous to a three-legged stool. Unfortunately, all the legs on the publication stool are not the same length, which results in both an uncomfortable as well as an unstable seat for technical reviewers. The traditional journal benefits from the author(s) output because it provides a usable product that the journal sells for a profit. In today’s world of publication metrics, if a paper is well cited, it improves the impact factor of the journal, which makes purchasing the journal (or having access to it) more desirable. Of course, the scientific community also benefits because the papers advance the science, as well as provide information that working professionals can use on problems/issues they may have to address. The author(s) also benefit from the process. The journal provides a platform that lets others in the field know what they are doing. Publication provides stature for the author(s) that ultimately can lead to recognition, promotion and higher salaries. The publication of a scientific contribution also provides self-satisfaction, at least to those not too jaded by the process. I am sure most of us still remember when our first paper was published, and still relish seeing our names in print. The third component of the process, the technical reviewer(s), ensures that papers submitted to a journal meet acceptable editorial and technical criteria. Other than the opportunity to read/learn something new ahead of the rest of the scientific community, technical reviewers obtain no direct benefits from the process. Despite this lack, I always considered reviewing part of the business of being a working scientist. If I do not review papers to assure their quality, why should I expect others to do the same when I submit a paper for publication; without competent reviews, the entire process falls apart. Good technical reviewing requires commitment from the reviewer. Based on personal experience, a thorough review of a 30–40 page double-spaced manuscript can take the better part of a day, even with today’s electronic communications. I prefer to print out the paper, check the citations, and then, while reading the manuscript, make marginal notes relative to editorial and technical issues. I then have to transfer those comments to an electronic form, check that I have clearly made the points I think are important, and then transmit the package back to the journal (editor). As noted, there are few if any tangible benefits for technical reviewing, and the process takes time. As a result, it should be incumbent on both the author(s) and the journal (editor) to make the process as aggravation-free as possible. If nothing else, both the author(s) and the editor should remember that an annoyed reviewer is unlikely to be particularly patient or generous with a manuscript. There are several things an editor can do to facilitate the review process. The review request normally transmits a title and an abstract. Most reviewers also would like to know the manuscript’s length; why is this information withheld? We are all busy people, and a manuscript’s length

Intervention and Documentation Reduce Exposure From Falls

Intervention and Documentation Reduce Exposure From Falls

Fatwa dalam Keuangan Syariah: Kekuatan Mengikat dan Kemungkinannya untuk Digugat Melalui Judicial Review

The main problems of this research are: first, the conceptual definition of fatwa in Islamic law in general and sharia financial law specifically; second, the legality or binding force of fatwa in sharia economic law; and third, the possibility of judicial review for fatwa issued by National Sharia Board (DSN). This research is a normative juridical study based on the primary, secondary, and tertiary legal sources. The conclusion drawn in this research is: first, fatwa is a legal opinion issued by an individual or a particular institution which has purpose or function to present any opinions regarding the matters related to life aspectsby considering the sharia principles or Islamic doctrines; second, the legality of fatwa appears due to the statement of the existing regulation stating that only fatwa issued by DSN which becomes the reference of sharia banking businesses. Even if DSN is considered as a non-government institution due to which its regulatory products do not have binding force unlike the regulations issued by the governmental institutions in general, fatwa still has its own binding nature, though substantively it is due to the existence of the Regulation of Bank of Indonesia related to the sharia banking provisions since if there is anything regarding sharia matters, Bank of Indonesia shall adopt the DSN fatwa. Third, as the consequence of the binding force, in which the government regulation might be legally reviewed, fatwa is also possible to be an object of a request for judicial review.

Coda: Kafka, Kadi, Kant

While Yusuf only knocked at the judicial gates of the European Court of Justice, another case managed to get passed the door of Europe’s highest court. This second judicial review case was – not without sublime irony – called Kadi; and it is that case that has become the modern point of reference for the relationship between international and European law. Presumed to be a Taliban terrorist, the plaintiff’s financial assets had also been frozen as a result of European legislation reproducing a United Nations Security Council Resolution. Kadi (“K”) tried to challenge the “arrest”, but the General Court rejected – on the same day and with the same reasons as in Yusuf – the request for judicial review; yet “K” appealed to the European Court of Justice by insisting that his (European) rights of due process (among other things) had been violated. When the European Court delivered its judgment, Kadi I instantly became a constitutional cause celebre, which has caused barrels of academic ink to be spilt. How has the Court decided Kadi II; and what are the broader philosophical questions involved in this story? This Coda explores the milestones of this Kafkaesque saga, in which “K” ultimately walked free after a decade of judicial battles.

Frequency and management of respiratory incidents in invasive home ventilation

There has been a rise in the number of patients requiring long-term ventilation, both in the in-hospital and the out-of-hospital setting. Despite this, little is known about the subsequent clinical course of these patients following hospital discharge. The purpose of this study was to determine the frequency and management of respiratory incidents in patients with invasive out-of-hospital ventilation living in a nursing home allied to a weaning centre. We evaluated retrospectively the protocols that are used to monitor the patients over a period of 2months. The average time from hospital discharge was 386±330days. Of the total 17 patients, 9 (53%) patients remained free from any respiratory incidents, while the remaining 8 (47%) patients were responsible for a total of 95 respiratory incidents. Patients that suffered respiratory incidents had been ventilated at home for an average of 194days, while the others were receiving out-of-hospital ventilation for an average of 557days. Desaturation (17), dyspnoea (17) and reduced general condition (10) were the most common respiratory incidents. Also, the use of an Ambu bag (bag valve mask; 17), request for a pneumologist review (12) and replacement of the tracheal cannula (7) were the most common interventions. Respiratory incidents are common in invasive home mechanical ventilation, and so home mechanical ventilation needed to be organized safely. Being allied to a weaning centre helps to organize invasive home mechanical ventilation in a safe manner over the long-term ventilation.

Restoring Trust in Organizations and Leaders: Enduring Challenges and Emerging Answers

Back to table of contents Previous article Next article Book ReviewsFull AccessRestoring Trust in Organizations and Leaders: Enduring Challenges and Emerging AnswersEric D. Lister, M.D., and Jeffrey L. Geller, M.D., M.P.H., Eric D. ListerSearch for more papers by this author, M.D., and Jeffrey L. GellerSearch for more papers by this author, M.D., M.P.H., EditorPublished Online:1 Apr 2013https://doi.org/10.1176/appi.ps.640412AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail by KramerRoderick M. and PittinskyTodd L.; New York, Oxford University Press, 2012, 304 pages, $59.99Trust is a subject of profound relevance for mental health professionals. Think of our patients’ struggles when trust has been tested, of our efforts at creating a therapeutic relationship marked by trust, and so on. Beyond the therapeutic dyad, relevance continues: Can we be assured, and assure others, that the health care institutions within which we work are worthy of our trust, not to mention our patients’ trust?Someone, obviously—editors and publisher—believe that this volume warrants broad readership, hence the request for a Psychiatric Services review. This reviewer was eager to read.The verdict: This is a somewhat interesting but fundamentally useless book.A compilation of 12 free-standing chapters, this volume is interesting first in the extensive documentation of diminished social trust (the problem that it seeks to address) and second in that the individual chapters are thoughtfully written.Several stand out. These include Roderick Kramer’s analysis of institutional trust failures and two chapters on apology. These are most relevant to a psychotherapist’s daily work.The book is largely useless, however, to anyone other than a social scientist wanting to know what a few colleagues have been doing in the field broadly defined as “trust research.” There is no effort to be comprehensive or synthetic. There is virtually no attempt to establish interdisciplinary linkages or meaningfully connect social science disciplines with the applied work of policy creation or organizational leadership. There is precious little effort to shed the argot of sociology in favor of more universally accessible language. If one is looking for practical guidance, the suggestions often offered at chapter’s end are, quite simply, facile.It is baffling beyond words that there is not one reference to South Africa’s Truth and Reconciliation Commission, arguably one of the most important social-psychological experiments relevant to trust and trust building to have taken place on the planet in the past century. The book’s subtitle is Enduring Challenges and Emerging Answers. If it had been “A Collection of Essays and Research Findings for the Social Scientist,” the gap between the promise of the book and what it delivers would have been diminished. That is to say, the book itself would have been more trustworthy relative to the expectation set by its title.Kramer and Pittinsky’s work demonstrates academia’s difficulty establishing a useful dialogue with those who are interested in translating theory into action. In the business literature (not without its own problems) many of the best books are first synopsized in Harvard Business Review (HBR), where editorial standards require rigorous thinking and solid research. HBR also expects authors to deliver an integrated message rather than a series of disconnected propositions and to bend to the wheel of translation, guiding the reader toward meaningful applicability in the context of real-world challenges.Of course, there is a marketing dimension to this practice, but when “marketing” takes the form of summarizing important ideas in concise and relevant ways, the problem lies where, exactly . . .? Social scientists would do well to reflect on whether a similar practice might make the work of their discipline more useful outside the ivory tower.Dr. Lister is managing director of Ki Associates, Portsmouth, New Hampshire.Dr. Lister has no relationship with Harvard Business Review. FiguresReferencesCited byDetailsCited byNone Volume 64Issue 4 April 2013Pages e6-e6 Metrics Dr. Lister has no relationship with Harvard Business Review.PDF download History Published online 1 April 2013 Published in print 1 April 2013

Consultoria em patologia cirúrgica mamária: variabilidade interobservador no diagnóstico de lesões proliferativas intraductais atípicas

To evaluate the agreement about the histopathological diagnosis of intraductal proliferative breast lesions between general pathologists and a specialist in breast pathology. This was an observational, cross-sectional study of 209 lesions received in consultation at the Breast Pathology Laboratory of the School of Medicine, Federal University of Minas Gerais, from 2007 to 2011, comparing the original diagnosis and the review. We included only cases with a formal request for review and cases in which the original diagnosis or reviewer's diagnosis showed proliferative lesions, pure ductal carcinoma in situ, ductal carcinoma in situ associated with microinvasion or associated with invasive carcinoma. The kappa index and percent concordance were used in the statistical analyses. A moderate agreement was observed between the original histopathological diagnosis and the second opinion (kappa=0.5; percentual concordance=83%). After the review, the diagnosis of malignancy was confirmed in 140/163 cases (86%) and the diagnosis of benign lesions was confirmed in 34/46 cases (74%). Regarding specific diagnosis, we observed moderate agreement between the original diagnosis and the reviewer's diagnosis (136/209 cases; kappa=0.5; percent concordance=65%). The highest disagreement was observed in cases of ductal carcinoma in situ with microinvasion (6/6 cases; 100%). Important discordance was observed in cases of atypical ductal hyperplasia (16/30 cases; 53%) and ductal carcinoma in situ (25/75 cases; 33%). Regarding the histological grade of ductal carcinoma in situ, we observed good agreement between the original diagnosis and the review (29/39 cases; kappa=0.6, percent agreement=74%). Our data confirm that intraductal proliferative breast lesions, especially atypical ductal hyperplasia, ductal carcinoma in situ and ductal carcinoma in situ with microinvasion show relevant discrepancies in the histopathological diagnoses, which may induce errors in therapeutic decisions.

Diagnostic sensitivity for invasive cervical carcinoma of high risk HPV tests performed on SurePath&amp;trade; liquid-based pap specimens

We thank Dr Nance for providing additional data on his experience with Hybrid Capture 2 (HC2) (Qiagen NV, Hilden, Germany) Laboratory Developed Testing (LDT) from the SurePath™ (Becton-Dickinson, Franklin Lakes, NJ, USA) vial. As mentioned previously, we believe this is the kind of retrospective data that the laboratory profession should be monitoring nationwide,1,2 especially given proposed extended five year screening intervals for many women with negative high risk (hr) HPV test results.3 The SurePath™ HC2 hrHPV LDT data cited by Dr Nance differs significantly from published data reported by several US academic centers. A study from Emory University of patients with ASC-H (atypical squamous cells - cannot exclude high grade squamous intraepithelial lesion) Sure-Path™ cytologic findings, for example, reported positive hrHPV HC2 LDT results from the SurePath™ vial in only 11 of 21 patients (52%) with follow-up CIN3 biopsy findings of 48 of 61 patients (79%) with follow-up CIN2 biopsy findings.4 More recently, Johns Hopkins University, reported positive hrHPV HC2 LDT results from the SurePath™ vial in 48 of 57 patients (84%) with HSIL SurePath™ cytology results, zero of six patients with SurePath™ cytologic findings of adenocarcinoma, and one of two patients with SurePath™ cytologic findings of squamous cell carcinoma.5 Since current achievable standards have been proposed that an HPV test should have clinical sensitivity to detect at least 89%–95% of existing CIN3+ lesions,6 these published findings and a number other cautionary observations we made in our initial report7 should be of concern regarding this widespread LDT. Furthermore, since SurePath™ HPV testing is not standardized according to any US Food and Drug Administration (FDA)-validated protocol, it is not possible to reliably extrapolate findings from any one laboratory to others. In fact, we are not aware of any published SurePath™ hrHPV LDT validation study which has published its methodology in sufficient detail so that it might be independently implemented and verified by other laboratories. Under current regulations, SurePath™ hrHPV LDT methods cannot be promoted by the manufacturers. LDT methods used in practices appear to vary quite widely, based on conversations with individual laboratories. Therefore, we applaud Dr Nance’s recent announcement to introduce in his laboratory co-collection of HPV test specimens in a separate FDA-approved collection vial. This, of course, is the approach the SurePath™ manufacturer itself recommended in its June 8, 2012 Technical Bulletin (BD Diagnostics, personal communication, June, 2012). Dr Nance’s report of positive hrHPV SurePath™ vial LDT results in seven of seven patients with HPV testing within 5 years of a diagnosis of cervical squamous cell carcinoma is itself somewhat surprising. Available international data indicate that negative hrHPV test results increase significantly as testing is less proximate to the time of diagnosis, probably due to increased difficulty in sampling infected lesional cells (sampling false negatives).8 In the largest available US study, baseline HC2 hrHPV test results collected in FDA-approved Specimen Transport Medium (STM) vials within 5 years of cervical cancer diagnoses were positive at baseline in only 60 of 87 cervical cancer patients (69%).9 It would be useful to know the full details of the LDT method(s) used by Dr Nance’s laboratory during the time periods mentioned, who originally developed this methodology, when the methodology was developed, and to have more information on the proximity of the seven HPV tests to the final diagnoses of squamous carcinoma. Ideally, in our opinion, what is needed is an FDA-approved SurePath™ hrHPV methodology based on supporting clinical trial data, so that user laboratories nationwide that wish to perform HPV testing from the SurePath™ vial can implement a standardized FDA-validated HPV testing method. Both the American Cancer Society and the American College of Obstetricians and Gynecologists now recommend that only FDA-approved HPV test methods be relied on in cervical screening.3 Laboratories choosing not to follow professional organization and manufacturer recommendations should make their validation data available upon request for independent review along with detailed information on the precise HPV testing method(s) they have used. Only then can findings be scientifically tested and independently scrutinized for validity and reproducibility. Patients deserve to be tested using scientifically sound methods. Clinicians should be able to trust that HPV testing used for patient care has been determined to meet current standards established through rigorous FDA trials and independent review. Until laboratories using LDT for HPV testing are willing to share their detailed methods and data so that their testing results are open to scientific scrutiny, reliance on FDA-approved testing methods is prudent.

Boots’s request for review over PDA Union application rejected

Boots’s request for review over PDA Union application rejected