Katrin S. Kohl

Guillain-Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data.

ames J. Sejvara,∗, Katrin S. Kohla, Jane Gidudua, Anthony Amatob, Nandini Bakshic, Roger Baxterc, ale R. Burwend, David R. Cornblathe, Jan Cleerbout f, Kathryn M. Edwardsg, Ulrich Heiningerh, ichard Hughes i, Najwa Khuri-Bulos j, Rudolf Korinthenbergk, Barbara J. Lawl, Ursula Munrom, elena C. Maltezoun, Patricia Nello,1, James Oleskep, Robert Sparksq, Priscilla Velentgasr, atricia Vermeers, Max Wiznitzer t, The Brighton Collaboration GBS Working Group2

The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI)

UNLABELLED To further scientific progress of immunization safety, comparability of data from clinical trials and surveillance systems is essential. Comparability requires the availability of standardized case definitions for adverse events following immunization (AEFI) and guidelines for case determination, recording and data presentation. METHOD International collaborative working groups, consisting of professional volunteers from developed and developing countries, conduct systematic literature reviews to develop 50-100 AEFI definitions. Case definitions are finalized after a comment period by a reference group consisting of organizations concerned with immunization safety, and will be disseminated via the world-wide-web and other means for free world-wide use. RESULTS Literature reviews yielded substantial diversity in data collection and presentation. We have developed standardized case definitions together with guidelines for use in clinical trials and surveillance systems. CONCLUSIONS Diversity in safety methods leads to considerable loss of scientific information. We have built the necessary international network of currently about 300 participants from patient care, public health, scientific, pharmaceutical, regulatory and professional organizations to develop and assess standardized AEFI case definitions and guidelines. Evaluation studies, global implementation, ongoing definition development and a continuously growing network will be essential for the success of the collaboration.

A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case definition and guidelines as an adverse event following immunization as well as the rationale for selected decisions about the case definition for a local reaction at or near the injection site are explained in the Preamble section. The case definition is structured in 2 levels of diagnostic certainty: level 1 includes any description of morphological or physiological change at or near the injection site that is described or identified by a healthcare provider. Level 2 is any description of morphological or physiological change at or near injection site that is described by any other person. In Guidelines section, the working group recommends to enable meaningful and standardized data collection, analysis, and presentation of information about a local reaction at or near the injection site. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographic region, and whether the source of information is a prospectively designed clinical trial, a post-marketing surveillance or epidemiologic study, or an individual report of a local reaction at injection site.

Public response to the 2009 influenza A H1N1 pandemic: a polling study in five countries.

BACKGROUND Many important strategies to reduce the spread of pandemic influenza need public participation. To assess public receptivity to such strategies, we compared adoption of preventive behaviours in response to the 2009 H1N1 influenza pandemic among the public in five countries and examined whether certain non-pharmaceutical behaviours (such as handwashing) were deterrents to vaccination. We also assessed public support for related public health recommendations. METHODS We used data from simultaneous telephone polls (mobile telephone and landline) in Argentina, Japan, Mexico, the UK, and the USA. In each country, interviews were done in a nationally representative sample of adults, who were selected by the use of random digit dial techniques. The questionnaire asked people whether or not they had adopted each of various preventive behaviours (non-pharmaceutical--such as personal protective and social distancing behaviour--or vaccinations) to protect themselves or their family from H1N1 at any point during the pandemic. Two-tailed t tests were used for statistical analysis. FINDINGS 900 people were surveyed in each country except the USA where 911 people were contacted. There were wide differences in the adoption of preventive behaviours between countries, although certain personal protective behaviours (eg, handwashing) were more commonly adopted than social distancing behaviours (eg, avoiding places where many people gather) across countries (53-89%vs 11-69%). These non-pharmaceutical behaviours did not reduce the likelihood of getting vaccinated in any country. There was also support across all countries for government recommendations related to school closure, avoiding places where many people gather, and wearing masks in public. INTERPRETATION There is a need for country-specific approaches in pandemic policy planning that use both non-pharmaceutical approaches and vaccination. FUNDING US Centers for Disease Control and Prevention and the National Public Health Information Coalition.

Usefulness of partner notification for syphilis control.

BACKGROUND AND OBJECTIVES In the United States, the recent syphilis epidemic has been followed by the lowest rates in 40 years. Syphilis control in the United States traditionally emphasizes partner notification; however, its role in elimination efforts remains undefined. GOAL OF THE STUDY To describe and compare outcome measures of partner notification during and after the epidemic. STUDY DESIGN Descriptive analysis of data obtained from interview records of patients with early syphilis in Louisiana during 1993 through 1996. RESULTS Of 12,927 patients with early syphilis, 3,245 (25%) were identified through partner notification. A total of 7,120 (55%) patients named at least one infected contact. Patients named a mean of 2.3 contacts, resulting in 29,248 named contacts; of these, 22,825 (78%) were examined. A total of 9,374 (41%) of examined contacts were infected, including 18% who were newly identified as infected. No substantial differences were found between epidemic and postepidemic years. CONCLUSION Partner notification is successful in identifying and treating a large number of infected persons. However, complementary strategies will be needed to eliminate syphilis.

Guidelines for collection, analysis and presentation of vaccine safety data in pre-and post-licensure clinical studies

Jan Bonhoeffer, Adwoa Bentsi-Enchill, Robert T. Chen, Margaret C. Fisher, Michael S. Gold, Katharina Hartman, Ulrich Heininger, Bernard Hoet, Thomas Jefferson, Najwa Khuri-Bulos, Katrin S. Kohl, S. Michael Marcy, David Nalin, Robert Pless, Hernan Sanabria-Rojas, Karen Sleeman, Robert Wise and The Brighton Collaboration Methods Working Group

Guidelines for collection, analysis and presentation of vaccine safety data in surveillance systems

Jan Bonhoeffer, Adwoa Bentsi-Enchill, Robert T. Chen, Margaret C. Fisher, Michael S. Gold, Katharina Hartman, Ulrich Heininger, Bernard Hoet, Thomas Jefferson, Najwa Khuri-Bulos, Katrin Kohl, S. Michael Marcy, David Nalin, Robert Pless, Hernan Sanabria-Rojas, Karen Sleeman, Robert Wise and The Brighton Collaboration Methods Working Group

Viscerotropic disease: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

iscerotropic disease: Case definition and guidelines for collection, analysis, and resentation of immunization safety data ark D. Gershmana,∗, J. Erin Staplesb, Adwoa D. Bentsi-Enchill c, J. Gabrielle Breugelmansd, lacus S. Britoe, Luiz Antonio Bastos Camachof, Pascale Cotting, Cristina Domingoh, Anna Durbin i, oaquim Gasconj, Fouzia Guenanechek,1, Edward B. Hayes j, Zsuzsanna Jelenik l, Alena Khromavam, einaldo de Menezes Martinsn, Mario Masana Wilsono,2, Nathalie Massyp, Abdulsalami Nasidiq, atthias Niedrigh, Adam Sherwatr,3, Theodore Tsai s, Anna Vilella j, Mary Elizabeth Wilsont, atrin S. Kohla , The Brighton Collaboration Viscerotropic Disease Working Group

A UMLS-based spell checker for natural language processing in vaccine safety

BackgroundThe Institute of Medicine has identified patient safety as a key goal for health care in the United States. Detecting vaccine adverse events is an important public health activity that contributes to patient safety. Reports about adverse events following immunization (AEFI) from surveillance systems contain free-text components that can be analyzed using natural language processing. To extract Unified Medical Language System (UMLS) concepts from free text and classify AEFI reports based on concepts they contain, we first needed to clean the text by expanding abbreviations and shortcuts and correcting spelling errors. Our objective in this paper was to create a UMLS-based spelling error correction tool as a first step in the natural language processing (NLP) pipeline for AEFI reports.MethodsWe developed spell checking algorithms using open source tools. We used de-identified AEFI surveillance reports to create free-text data sets for analysis. After expansion of abbreviated clinical terms and shortcuts, we performed spelling correction in four steps: (1) error detection, (2) word list generation, (3) word list disambiguation and (4) error correction. We then measured the performance of the resulting spell checker by comparing it to manual correction.ResultsWe used 12,056 words to train the spell checker and tested its performance on 8,131 words. During testing, sensitivity, specificity, and positive predictive value (PPV) for the spell checker were 74% (95% CI: 74–75), 100% (95% CI: 100–100), and 47% (95% CI: 46%–48%), respectively.ConclusionWe created a prototype spell checker that can be used to process AEFI reports. We used the UMLS Specialist Lexicon as the primary source of dictionary terms and the WordNet lexicon as a secondary source. We used the UMLS as a domain-specific source of dictionary terms to compare potentially misspelled words in the corpus. The prototype sensitivity was comparable to currently available tools, but the specificity was much superior. The slow processing speed may be improved by trimming it down to the most useful component algorithms. Other investigators may find the methods we developed useful for cleaning text using lexicons specific to their area of interest.

Developments in the screening for Chlamydia trachomatis: a review

Many studies have evaluated selective screening criteria for women in various settings. Most have concluded and all guidelines recommend that all women aged < 25 be screened yearly for C. trachomatis infection. Behavioral criteria, such as the number of sex partners, new or more than one sex partners, and previous infection, also can serve as criteria for screening women aged > 25. Because re-infection rates are high and occur within a few months, complications may be reduced further if partners are treated and women rescreened 4 to 6 months after initial infection. Revised recommendations for C. trachomatis screening programs have stated that more frequent screening may be considered among women < 20 and those with recent infection. Screening in nontraditional settings and careful evaluation of local prevalence and risk factor information should be encouraged. Private providers and emergency room providers should discuss screening recommendations and adopt a C. trachomatis screening policy for the population they serve. The HEDIS measure should serve to encourage at least annual screening of 15- to 25-year-old sexually active females through providers linked to managed care organizations. In general, high yields (ie, percentage of tests that are positive) in nontraditional settings and enhanced feasibility and acceptability of urine-based tests may encourage further innovative approaches to reach and screen populations at risk. Several issues remain to be addressed to increase the effectiveness of screening efforts. If more sensitive amplification tests are used widely, more infected persons will be identified and treated, and transmission patterns may change, particularly if partner treatment also occurs. Current screening criteria should continue to be re-evaluated. An important issue that affects testing methods includes the possible need for confirmation testing when using NAATs if the prevalence of C. trachomatis is less than 2%. If the sensitivity of an NAAT is 85% and specificity is 99%, in a hypothetical population of 10,000 with a prevalence of 2%, the positive predictive value is 170/268 (63%). A second important issue affecting testing methods and feasibility of using NAATs for screening large numbers of individuals is the pooling of urine specimens, which has been evaluated in several studies and found to be very effective for reducing costs. A research issue for pooling is the determination of the most cost-effective prevalence levels for pooling. An additional research question is in which populations should a NAAT be used for detection of C. trachomatis and N. gonorrhoeae. There are no recommendations for the routine screening of men because of the paucity of data showing that this strategy can reduce sequelae. The CDC is conducting a multisite study to examine the feasibility, acceptability, and usefulness of screening of asymptomatic men. There are a few studies have determining cost-effective prevalence threshold levels, particularly with NAATs. A recently developed decision analysis model by CDC designed to maximize the effectiveness of screening strategies for C. trachomatis infections may be useful for decision makers. It is intended to serve as an easy and flexible tool to determine cost effectiveness at a local level and takes into account positivity rates and test performance characteristics (SOCRATES). It is unclear if recurrent infection is caused by true re-infection by the same or a different partner or recurrence of initial infection. Recurrence may be caused by persistence of C. trachomatis or antibiotic resistance. This distinction is of scientific interest because the appropriate intervention differs (eg, identification of risk factors for the former and microbiologic investigations for the latter). Effective partner management and retesting are critical to reducing sequelae of C. trachomatis infection. Screening for C. trachomatis infection remains an essential component of C. trachomatis control. It is cost effective, most infections are asymptomatic, and symptom-based health care seeking and testing identify few of those infected. The likelihood that opportunities for screening are missed is high particularly in non-STD clinic settings. Local studies using NAATs to determine C. trachomatis prevalence and risk factors are helpful to health care providers so they can make evidence-based decisions on who to screen. The use of nontraditional, non-clinic-based test settings should be explored further. We have focused on summarizing the medical evidence regarding recommendations for screening for C. trachomatis. High-risk populations for C. trachomatis infection may overlap with populations for other STDs, and comprehensive STD prevention programs that involve a range of STD service providers are needed to successfully reduce the STD-related health burden in the population.