Assessment Committee Research Articles

Role of Health Technology Assessment in Drug Policies: Korea

South Korea is the first Asian country to mandate the submission of pharmacoeconomic data for reimbursement decision making. For a new drug to be listed, it must demonstrate its value in terms of comparative effectiveness and cost effectiveness. The Health Insurance Review and Assessment Service (HIRA) judges the submitted drug’s value and decides whether its coverage is appropriate on the basis of the recommendation of the Pharmaceutical Benefit Coverage Assessment Committee. Once the drug has been accepted by HIRA, the National Health Insurance Service and the sponsoring company negotiate the price and expected sales volume. Even if HIRA acknowledges the value of the drug, it cannot be listed if the negotiation fails. In the off-patent market, generic and original branded drugs are treated equally in terms of pricing. Once generics enter the market, both drug prices should be lowered to 53.55% or less of the on-patent price. Since the current system was implemented, concerns have been raised about a decline in the accessibility of new drugs, especially for high-priced drugs used to treat serious diseases. In 2013, several measures had been introduced aimed at improving the accessibility of these drugs. A risk-sharing scheme and an increase in the maximum acceptable cost-effectiveness ratio were subsequently initiated. Although these schemes have been successful in improving access to high-priced drugs, they are often criticized for reducing transparency in pricing. Finding a balance between accessibility and efficiency is still a challenge in Korea.

New safety signals assessed by the Pharmacovigilance Risk Assessment Committee at EU level in 2014–2017

ABSTRACTBackground: Safety monitoring of all drugs throughout their entire life cycle is mandatory in order to protect the public health. Our objective was to describe all new safety signals assessed at EU level by the Pharmacovigilance Risk Assessment Committee (PRAC).Methods: Publicly available data on signals assessment from PRAC meeting minutes for the period January 2014–November 2017 were analyzed and classified.Results: A total of 239 new signals for 194 drugs/drug combinations/therapeutic classes were evaluated by PRAC. A total of 154 signals were triggered by spontaneous reporting, 31 by literature case reports, and 26 by observational studies. In 188 signals, the drugs involved were authorized for more than 5 years. The drug classes for which most signals were detected were antineoplastic/immunomodulators (n = 75), anti-infectives (n = 34), and drugs acting on the nervous system (n = 27). Signals were triggered for drug interactions (n = 15), in utero exposure (n = 7), medication errors (n = 6), and for different disorders, among which the skin/subcutaneous tissue disorders were more common. PRAC recommendations consisted in label updates (n = 86), in Direct Healthcare Professional Communications (n = 17), and in eight recommendations for a more complex evaluation through referral procedures.Conclusions: Most new signals assessed were triggered by spontaneous reporting and led to routine risk minimization measures, such as updating the product information.

Safety and Efficacy of Anti-Vascular Endothelial Growth Factor Therapies for Neovascular Age-Related Macular Degeneration: A Report by the American Academy of Ophthalmology

To review the evidence on the safety and efficacy of anti-vascular endothelial growth factor (VEGF) therapies for the treatment of neovascular age-related macular degeneration (AMD). A literature search of the PubMed and Cochrane Library databases was last conducted in February 2017; there were no date restrictions, and the search was limited to studies published in English. The combined searches yielded 191 citations, 28 of which were selected because they were clinical trials and were deemed clinically relevant for the Ophthalmic Technology Assessment Committee Retina/Vitreous Panel to review in full. The panel methodologist then assigned a level of evidence rating to each study. Sixteen of the 28 citations provided level I evidence supporting the use of anti-VEGF agents for neovascular AMD, including intravitreal ranibizumab, aflibercept, and bevacizumab. Eight studies reviewed provided level II evidence, and 4 studies provided level III evidence, but only the level I studies are included in this assessment. There are long-term follow-up data on the efficacy of ranibizumab and bevacizumab (≥5 years), but these data are subject to the bias of incomplete follow-up. Review of the literature indicates that intravitreal injection of anti-VEGF therapy is safe and effective for neovascular AMD over 2 years, the period for which data are available. Further research is needed to evaluate the long-term safety and comparative efficacy of these agents.

Conversing with climate change skeptics

Last year at a reception at the Austrian embassy in Washington, DC, I met a climate change skeptic. Although I remain swayed by the case that humans’ emission of carbon dioxide and other greenhouse gases has warmed Earth’s lower atmosphere, I did not dismiss the skeptic’s contrary case. We even continued the discussion cordially through email.I don’t see such conversations as capitulation or as an opportunity to convert people to the near-consensus position on climate change. Rather, I’m genuinely curious about contrarians’ grounds for skepticism in the face of overwhelming scientific evidence.Consider, for example, the adverse health effects of smoking tobacco. By the mid 1950s, British epidemiologists Richard Doll and Austin Bradford Hill had established a compelling link between lung cancer and smoking. In 1962 the Royal College of Physicians (the UK equivalent of the American Medical Association) issued the report Smoking and Health, which guided doctors on the issue. To boost the report’s impact, RCP held a press conference, the college’s first ever.Contemporary reactions to the report from individuals and editorialists appear in historian David Kynaston’s book Modernity Britain: 1957–1962 (2014). “Quite honestly, I think that the end of one’s life is probably more in the hands of almighty God, you know, than in my own hands or the hands of the tobacco manufacturers,” said a pack-a-day smoker to a BBC TV interviewer after the report came out.It’s tempting to see a parallel. Smokers deny the health effects of tobacco because they don’t like the solution: cutting back on cigarettes. Skeptics deny the warming effects of greenhouse gases because they don’t like the solution: cutting back on fossil fuels. But the skeptics have a point. Whereas giving up smoking is an unqualified benefit, that’s not the case for fossil fuels. Giving them up would have a serious effect on the world’s economy. I happen to believe that we should reduce the burning of fossil fuels for energy, but I acknowledge the counterargument.The alleged inaccuracy of climate models is a drum that skeptics continue to beat. Charles Keeling began monitoring atmospheric carbon dioxide on Mauna Kea in 1958. By the time the US National Academy of Sciences issued its report Changing Climate: Report of the Carbon Dioxide Assessment Committee in 1983, the CO2 concentration had risen by around 10%. In the same time span, Earth’s mean temperature could, with reason, be claimed to have remained more or less constant. To make the case that greenhouse gases cause warming, climate scientists had to resort to models. Earth’s climate is a complex system. Uncertainties remain, notably to do with aerosols, in the models that seek to capture its principal features.I’m not qualified to discuss the details of modeling the climate. However, I can point out that the current mean temperature is 1 °C higher now than it was in the 1950s. As the temperature continues to rise, it’s becoming harder to deny that climate change is happening, regardless of the accuracy of models, which happens to be high. My interlocutor from the Austrian embassy party concedes that the lower atmosphere is warming. He remains skeptical that humans are responsible for most of the warming.What would it take to convince him and other skeptics? For answers, I looked at another Earth sciences controversy that took four decades to resolve: plate tectonics. Various lines of evidence strongly suggested that Earth’s continents slid across the planet’s surface. While conceding the strength of the evidence, skeptics pointed out that a mechanism and energy source for the titanic movements were lacking.But as Naomi Oreskes observed at the end of the introduction to the book Plate Tectonics: An Insider’s History of the Modern Theory of the Earth (2001), the skeptics eventually came around and joined their colleagues in elucidating the theory: “Scientists who had been raised to believe that the earth’s crust was fixed, that continental drift was impossible, and that Alfred Wegener was a crank, now contributed their own scientific brilliance to showing how the crust moved, what made it move, and that Wegener, in his overall insight if not in every detail, was right. This, perhaps, is the most important part of the story, a story of scientists who realized what they had previously believed was wrong, and set it right.”© 2018 American Institute of Physics.

Safety and effectiveness of combined scoring balloon and paclitaxel-coated balloon angioplasty for stenosis in the hemodialysis access circuit.

To evaluate the safety and effectiveness of combined scoring balloon (SB) and paclitaxel-coated balloon (PCB) angioplasty for stenosis in the dysfunctional hemodialysis access circuit. Patients were referred from outpatient dialysis centers by their nephrologists because of dysfunctional dialysis access circuit. Fistulogram/graftogram was performed by experienced interventional radiologists. Those with in-stent stenosis, stent edge stenosis or vessel diameter at the culprit segment larger than 6mm were excluded. Angioplasty of the stenotic segment was performed with SB and followed by PCB. All study outcomes were defined according to the Society of Interventional Radiology technology assessment committee reporting standards for percutaneous interventional procedures in dialysis access circuit. A total of 23 patients received combined SB/PCB angioplasty for stenosis of hemodialysis access circuit which included 15 fistulas and 8 grafts. There were 10 men and 13 women with a mean age of 63.3±2.7 (SD) years (range: 37-85years). The technical success and clinical success rates were both 100%. There were no complications during or after the procedures. The target lesion primary patency rates at 3, 6 and 12months were 91.3%, 69.6%, and 45.2%, respectively and the estimated median target lesion restenosis (TLR) free duration was 11.0months (95% confidence interval [CI]: 5.1-16.9months). In patients with a recurrent stenosis, the median TLR-free duration of combined angioplasty was significantly higher than that of prior angioplasty with plain balloon (10.2months [95% CI: 6.4-14.0months] vs. 4.2months [95%CI: 2.1-6.4months]) (P=0.047). The mean TLR-free duration was significantly higher in patients with a juxta-anastomotic stenosis than those with non-juxta-anastomotic lesion (21.3months [95% CI: 14.7-28.0months] vs. 8.2months [95% CI: 5.1-11.4months]) (P=0.004). Combined SB/PCB angioplasty is safe and effective for the hemodialysis access stenosis.

Selective Progesterone Receptor Modulators for the Medical Treatment of Uterine Fibroids with a Focus on Ulipristal Acetate.

Uterine fibroids are the most frequent benign tumours in women of child-bearing age. Their symptoms are diverse and the quality of life of the women affected can be significantly impaired. While treatment to date has been primarily by means of surgical intervention, selective progesterone receptor modulators (SPRMs) open up new medication-based treatment options. EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recently completed its review of ESMYA® (ulipristal acetate, 5 mg), following reports of serious liver injury, including liver failure leading to transplantation in postmarketing settings. We will provide some information on the PRAC's recommendations to minimize this risk. Nevertheless, the effectiveness and safety of the SPRM ulipristal acetate (UPA), both with regard to preoperative administration and with regard to an intermittent administration as long-term treatment for patients with symptomatic uterine fibroids, have been shown in several clinical studies (PEARL I–IV).

Characteristics of drugs safety signals that predict safety related product information update.

PurposeInvestigation of drug safety signals is one of the major tasks in pharmacovigilance. Among many potential signals identified, only a few reflect adverse drug reactions requiring regulatory actions, such as product information (PI) update. Limited information is available regarding the signal characteristics that might predict PI update following signal evaluation. The objective of this study was to identify signal characteristics associated with PI updates following signal evaluation by the European Medicines Agency Pharmacovigilance Risk Assessment Committee during 2012 to 2016.MethodsA comparative study was performed based on data from 172 safety signals. Characteristics of signals were extracted from the European Pharmacovigilance Issues Tracking Tool database. Multivariable logistic regression analysis was used to assess the relationship between signal characteristics and the decision to update the PI.ResultsMultivariable logistic regression analysis showed that the presence of evidence in multiple types of data sources (adjusted odds ratio [OR] 7.8 95% CI [1.5, 40.1]); mechanistic plausibility of the drug‐event association (adjusted OR 3.9 95% CI [1.9, 8.0]); seriousness of the event (adjusted OR 4.2 95% CI [1.3, 13.9]); and age of drugs ≤5 years (adjusted OR 3.9 95% CI [1.2, 12.7]) were associated with the decision to change the PI (P < 0.05).ConclusionsThis study identified 4 characteristics of drug safety signals that have shown to be associated with PI changes as outcome of signal evaluation. These characteristics may be used as criteria for selection and prioritization of potential signals that are more likely to necessitate product information updates.

Cross-cultural validation of the Child Adolescent Teasing Scale for Colombian students.

ABSTRACTObjective:to carry out the cross-cultural validation of the instrument “Child Adolescent Teasing Scale” for the Colombian student population. Method:methodological study carried out with students aged 8 to 15, from public and private educational institutions in the municipality of Ibagué, Colombia. The form for the characterization of students and the Child Adolescent Teasing Scale were used. Results:the cross-cultural adaptation process was organized in seven steps: comparison of the Spanish version of the instrument with the original English version, back-translation, consensus version, face validity and terminology adjustment by students, face and content validity by experts, assessment committee for the final version, pilot test and reliability. Conclusion:the version adapted to the Spanish spoken in Colombia of the Child Adolescent Teasing Scale (Escala de burlas para niños y adolescentes), which assesses the frequency and distress caused by teasing, showed desirable results in terms of validity and reliability.

WHO/Europe and ECDC intensify collaboration on infectious diseases and health emergencies

Dr Zsuzsanna Jakab, WHO Regional Director for Europe, and Dr Andrea Ammon, Director of the European Centre for Disease Prevention and Control (ECDC), met at the WHO Regional Office in...

New Survey Process Features Retooled Regulations, F-Tags

New Survey Process Features Retooled Regulations, F-Tags

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Multicriteria decision analysis (MCDA) for health technology assessment: the Queensland Health experience.

Objectives In determining whether new health technologies should be funded, health technology assessment (HTA) committees prefer explicit to implicit methods of analysis in enhancing transparency and consistency of decision making. The aim of this study was to develop and pilot a multicriteria decision analysis (MCDA) framework for the Queensland Department of Health HTA program committee, which weighted decision making criteria according to their perceived importance as determined by group consensus. Methods The criteria used in the MCDA framework were identified by reviewing the five unweighted criteria used in the existing process, consultation with committee members and literature review. Criteria were clearly defined and ordinal categories of lowest to highest preferred were assigned against which technology submissions would be rated. Criteria weights were determined through a discrete choice experiment (DCE) survey of committee members using validated software. Mean weighted technology scores were then used to guide deliberative discussions in determining final funding decisions. Results The MCDA framework created one additional criterion to the previous five. The criteria and their mean weights identified through the DCE survey were clinical benefit and safety (27.2%), quality of evidence (19.2%), implementation capacity (16.9%), innovation (15.4%), burden of disease and clinical need (13.3%) and societal and ethical values (8.0%). Criterion weights varied considerably between individual committee members, with one criterion having a difference of 36.9% between the highest and lowest preference weights. Following deliberative discussions, all but one of 10 submissions were awarded funding. The submission not supported received the third lowest score through the MCDA model. Conclusions This pilot application of an MCDA framework, as a complement to committee deliberation, conferred greater transparency and objectivity on HTA assessment of technologies. The framework converted an implicit, unweighted review process to one that is more explicit, flexible in weighting importance and pragmatic. What is known about the topic? HTA programs involve complex decision-making processes requiring the consideration of multiple criteria. Explicit methods of analysis that use weighted criteria according to their relative importance enhance transparency and consistency of decision making by HTA committees, and are preferred to implicit reviews using unweighted criteria. What does this paper add? This article describes the development and piloting of an MCDA framework that aims to improve transparency, objectivity and consistency of funding decisions of the Queensland HTA committee. Criteria were identified through a review of current processes, committee discussions and a literature review, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) quality of evidence system. Criteria were weighted using a discrete choice experiment involving committee members. Using weighted criteria, mean technology scores were calculated and incorporated into deliberative discussions to determine funding decisions. What are the implications for practitioners? The MCDA framework described here converted a more implicit, unweighted process to one that was more pragmatic, explicit and flexible in scoring HTA submissions. This framework may be useful to other HTA programs and could be expanded to resource allocation decision making in many other healthcare settings.

CHARACTERISTICS OF MANAGED ENTRY AGREEMENTS IN AUSTRALIA.

Australia relies on managed entry agreements (MEAs) for many medicines added to the national Pharmaceutical Benefits Scheme (PBS). Previous studies of Australian MEAs examined public domain documents and were not able to provide a comprehensive assessment of the types and operation of MEAs. This study used government documents approved for release to examine the implementation and administration of MEAs implemented January 2012 to May 2016. We accessed documents for medicines with MEAs on the PBS between January 2012 and May 2016. Data were extracted on Anatomical Therapeutic Classification (ATC), type of MEA (financial, financial with outcomes, outcomes, and subcategories within each group), implementation and administration methods, source of MEA recommendation, and type of economic analysis. Of all medication indication pairs (MIPs) recommended for listing, one-third had MEAs implemented. Our study of eighty-seven MIPs had 170 MEAs in place. The Government's expert health technology assessment (HTA) committee recommended MEAs for 90 percent of the eighty-seven MIPs. A total of 81 percent of MEAs were simple financial agreements: the majority either discounts (32 percent) or reimbursement caps (43 percent). Outcome-based MEAs were least common (5 percent). Ninety-two percent of MEAs were implemented and operated through legal agreements. Approximately half of the MIPs were listed on the basis of accepted claims of cost-minimization. Forty-nine percent of medicines were in ATC L group. Advice from HTA evaluations strongly influences the implementation of ways to manage uncertainties while providing access to medicines. The government relied primarily on simple financial agreements for the managed entry of medicines for which there were perceived risks.

Revealed and Stated Preferences of Decision Makers for Priority Setting in Health Technology Assessment: A Systematic Review.

There is much interest from stakeholders in understanding how health technology assessment (HTA) committees make national funding decisions for health technologies. A growing literature has analysed past decisions by committees (revealed preference, RP studies) and hypothetical decisions by committee members (stated preference, SP studies) to identify factors influencing decisions and assess their importance. A systematic review of the literature was undertaken to provide insight into committee preferences for these factors (after controlling for other factors) and the methods used to elicit them. Ovid Medline, Embase, Econlit and Web of Science were searched from inception to 11 May 2017. Included studies had to have investigated factors considered by HTA committees and to have conducted multivariate analysis to identify the effect of each factor on funding decisions. Factors were classified as being important based on statistical significance, and their impact on decisions was compared using marginal effects. Twenty-three RP and four SP studies (containing 42 analyses) of 14 HTA committees met the inclusion criteria. Although factors were defined differently, the SP literature generally found clinical efficacy, cost-effectiveness and equity factors (such as disease severity) were each important to the Pharmaceutical Benefits Advisory Committee (PBAC), the National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group. These findings were supported by the RP studies of the PBAC, but not the other committees, which found funding decisions by these and other committees were mostly influenced by the acceptance of the clinical evidence and, where applicable, cost-effectiveness. Trust in the evidence was very important for decision makers, equivalent to reducing the incremental cost-effectiveness ratio (cost per quality-adjusted life-year) by A$38,000(Australian dollars) for the PBAC and £15,000 for NICE. This review found trust in the clinical evidence and,where applicable,cost-effectiveness were important for decision makers.Many methodological differences likely contributed to the diversity in someof the otherfindings across studies of the same committee. Further work is needed to better understand how competing factors are valued by different HTA committees.

Lymphopenia and fumaric acid esters for psoriasis: a retrospective case series prompted by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommendations

Lymphopenia and fumaric acid esters for psoriasis: a retrospective case series prompted by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommendations

Orbital Implants in Enucleation Surgery: A Report by the American Academy of Ophthalmology

To compare the motility and complication rates of porous and nonporous implants after enucleation surgery. Literature searches of the PubMed and Cochrane Library databases were last performed in February 2017 to identify studies published between 2003 and 2017 on outcomes after enucleation surgeries in which a variety implants were used. The searches were limited to the English language with abstracts and yielded 43 articles, which the Ophthalmic Technology Assessment Committee Oculoplastics and Orbit Panel reviewed for relevancy. Twenty-five articles were considered to have met the search strategy, and the panel methodologist assigned ratings to them according to the level of evidence. Only 2 of the 25 articles identified met the criteria for level I evidence. Eighteen of the studies did not assess motility after enucleation surgery, and the 7 that did evaluate this metric involved porous implants. The studies that analyzed this outcome reported favorable results, but the results were not uniformly based on objective analysis. Both porous and nonporous implants were well tolerated, and complication rates were generally low for both types. In keeping with increasing surgeon preference for porous implants, most studies identified in this literature search involved the use of this type of implant. These implants resulted in excellent motility after enucleation surgery, although many studies did not assess this outcome. Regardless of implant type, major complications were rare, and infection was exceptionally uncommon after enucleation. Given the paucity of data on motility and the absence of direct, objective comparisons of porous and nonporous implants, definitive conclusions about the impact of implant material on motility cannot be made. Since few studies evaluated nonporous implants, direct comparisons cannot be made definitively between implant types, and future investigations are needed to enable a critical assessment.

Long-Term English Language Learners’ Educational Experiences in the Context of High-Stakes Accountability

Background/Context A large number of emergent bilinguals, also known as English language learners (ELLs), in secondary schools have experienced academic difficulties, grade repetition, inappropriate referrals to special education, and dropout. They are the most in danger of academic failure and in need of highly qualified instruction that meets their needs; however, they have received little attention from schools. To better understand secondary emergent bilinguals’ academic challenges, it would be necessary to examine their learning experiences throughout schooling, including language support programs and services provided, instructional practices and academic support implemented, and assessments administered to make their educational decisions. In particular, as the high-stakes accountability system has played a critical role during their course of schooling, it would be essential to examine how the accountability system has interacted with these underachieving emergent bilinguals. Purpose/Focus of Study This manuscript draws from a larger qualitative study (Kim, 2013) that investigated long-term ELLs’ history of schooling and their perceptions of language and academic learning experiences. The purpose of this analysis is to more closely examine the nature of language support received during participants’ K-12 schooling and their program placements in the context of their performance on state-mandated language and academic achievement tests. Experiences of participants who were retained and referred to and/or placed in special education serve to illustrate schools’ responses to these underachieving emergent bilinguals. Setting/participant This research study took place at a high school in central Texas. Eleven secondary emergent bilinguals who met the purpose of this research project participated in the study. The essential attributes of participants for inclusion were English language learners who (a) met the state eligibility criteria for classification as limited English proficiency, (b) had attended public schools in the United States for seven years or more, and (c) had at least a year of high school experience. Research Design A qualitative research design based on a constructivist, Naturalistic Inquiry (NI) paradigm was utilized to understand the reality of participants’ school challenges. This NI approach is appropriate to analyze concepts and themes derived from the exploratory cases of this population. Data Collection and Analysis Data sources were individual, semi-structured, and in-depth interviews and a variety of school documents that included each student's cumulative folder, Language Proficiency Assessment Committee (LPAC) documents, and academic assessment records. As the constant comparative method of data analysis was a core function of this research process, data analysis occurred concurrently with data collection. Triangulation among students’ recollections of their program placements, archival data, and informant (i.e., district bilingual and ESL professionals) interviews was used to ensure that the findings accurately reflected the actual phenomenon. Member checks, reflexive journaling, and peer debriefing were also utilized to ensure the trustworthiness of the study. Findings Participants in this study experienced multiple layers of limited opportunity to learn as they moved through the educational process. They began their schooling with inadequate bilingual education services in elementary grades, and many of them were retained and/or referred to special education, mainly due to their unsatisfactory scores on state-mandated assessments. Subsequently, participating ELLs all moved up to middle school where they received little English language support; their continued low scores on high-stakes assessments led to placement in remedial programs or intervention courses for state mandated tests. During their high school years, this pattern continued with the addition of End-Of-Course designated courses, remedial courses for preparing for state mandated tests, and credit recovery programs. Though state assessments should not be exclusively used to measure student learning, they were solely used to participating ELLs’ high-stakes instructional and placement decisions (e.g., retention, placement in remedial programs), which appeared to negatively affect participants’ educational trajectory by increasing the gaps in their opportunities to learn. Conclusions/Recommendations The participating ELLs’ experience of schooling fostered academic gaps due to their limited opportunities to learn, and they had been inadvertently excluded from the formal curriculum because schools in the district did not have adequate programs and services to address these learners’ linguistic and academic needs. Informed by social capital framework research and theory, findings suggest that participants’ gaps in learning continued to grow with each subsequent year of schooling, exacerbated by their limited access to appropriate language services and educational support, thereby rendering them struggling, low-achieving, long-term ELLs. Despite their academic challenges, participating ELLs remained eager to succeed in school, which raises a critical question regarding how well the educational system is prepared to provide these emergent bilinguals with high quality, rigorous programs that are responsive to their linguistic and academic needs.

Cognition in depression: Can we THINC-it better?

BackgroundCognitive compromise is a common experience for patients with depression and other mood disorders. Depressed patients sustain deficits in working memory and attentional distortions in emotional processing and negative attention biases, which may contribute to maintaining their depressive state. MethodsThe Mood Assessment and Classification (MAC) Committee comprised academic psychiatrists with clinical expertise in the management of mood disorders. The independently convened committee met to discuss contentious aspects of mood disorders diagnosis and assessment with the express aim of informing clinical practice and future research. ResultsThe Committee specifically identified cognition as an important aspect for clinicians to consider in the context of depression and mood disorders. This article highlights some of the barriers to assessment and proposes tools that have the potential to be implemented in clinical practice. LimitationsThe conclusions drawn within this article are based on expert opinion. We have noted the limitations of the literature that informs this opinion. ConclusionsAs cognitive ability has been closely linked to patients’ ability to achieve functional recovery, it is imperative that clinicians are able to identify patients with cognitive deficits and are equipped with tools to conduct effective cognitive assessments. Examining cognitive factors may generate a deeper understanding of the pathogenesis of depression and mood disorders which can ultimately be used to inform treatment.

SAGES technology and value assessment committee (TAVAC) safety and effectiveness analysis: LINX® reflux management system.

SAGES technology and value assessment committee (TAVAC) safety and effectiveness analysis: LINX® reflux management system.

Trend analysis of new health technology in dentistry

Objectives : Currently, it is being reported that new health technology (HT) is introduced and spread throughout Korea at a very fast rate. However, the current status of new HT related to dentistry has not been known or studied. Therefore, this study aims to understand the present state and awareness on dentistry-related domestic new HT via surveys and research, and thus apply this as a reference to construct an effective new HT-related system in the field of dentistry. Methods : The assessment status of New Health Technology Assessment (nHTA) committee was searched on the website for any updates on new HT5). The cases were searched in the range between Jan 1 2012 and Jul 31 2016 by submission date and were analyzed by year, division of technology, progress and major operating practitioner. Among those, technologies utilized by dentists were additionally analyzed. The survey result was obtained by combining responses of 25 participants from the workshop for new HT application and 11 members of Korean Association of Oral and Maxillofacial Surgeons (KAOMS). The workshop was co-hosted by KAOMS and Clinical Translational Research Center for Dental Science (CTRC) under Seoul National University Dental Hospital (SNUDH). Results : Most of the respondents to the survey have heard of new health technology but were unaware of the application procedure. 'Safety and effectiveness' was selected the most for things to consider when introducing new HT, followed by 'scientific evidence of the technology.' For new dental HT status, submissions between 2012 and Jul 31 2016 were analyzed by major operating practitioner, including cases where there are multiple practitioners. Yet, only 19 cases (17 %) of dentists were reported. Among 385 cases approved by nHTA, only 2 cases included dentists. Conclusions : Active publicity by the government on new HT and its application procedure, and continued interest and research in the dental and medical community is likely to be required for the development of dentistry.