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Existing high-priority target product profiles (TPPs) of the World Health Organization (WHO) establish important needs for tuberculosis (TB) diagnostic development. Building on this earlier work, this guidance series aims to provide study guidance for performing accuracy studies of novel diagnostic products that may meet the 4 high-priority WHO TPPs and thus enable adequate evidence generation to inform a WHO evidence review process. Diagnostic accuracy studies represent a fundamental step in the validation of all tests. Unfortunately, such studies often have limitations in design, execution, and reporting, leading to low certainty of the evidence about true test performance, which can delay or impede policy and scale-up decisions. This introductory paper outlines the following: (1) the purpose of this series of papers on study guidance; (2) WHO evidence needs and process for the development of policy guidelines for new TB diagnostic tests; and (3) study design considerations, ie, general diagnostic study considerations, intended use of test and role in the clinical pathway, choice of population and setting, index-test specific issues, suitable reference standard and comparators, study flow and specimen issues, and finally key issues beyond accuracy that should be considered. The other 4 papers in this series will provide more detailed guidance for each of the 4 WHO high-priority TPPs. By increasing the clarity around the clinical evaluation needs for tests that have the potential to meet the TPP specifications, we hope to support harmonized evidence generation and enable the WHO review process towards meeting the WHO End TB Strategy targets for reducing the incidence and mortality associated with TB., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Neonatal infections affect about 7 million neonates causing over 600 000 deaths every year. Estimating the burden is challenging as there are multiple reporting criteria and definitions for serious bacterial infections in neonates. Essential criteria for reporting serious neonatal bacterial infections have recently been published as the STROBE-NI checklist and, in the context of maternal vaccination, definitions have been published by the Brighton Collaboration Global Alignment of Immunization safety Assessment in pregnancy (GAIA) project. Standardisation of reporting criteria is essential to allow data comparability. This an important step in providing a clearer picture of the burden of serious bacterial infections in neonates and a welcome progress for guiding new investments in interventions., (© The Author 2017. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Diagnosis of pertussis remains a challenge, and consequently research on the risk of disease might be biased because of misclassification. We quantified this misclassification and corrected for it in a case-control study of children in Philadelphia, Pennsylvania, who were 3 months to 6 years of age and diagnosed with pertussis between 2011 and 2013. Vaccine effectiveness (VE; calculated as (1 - odds ratio) × 100) was used to describe the average reduction in reported pertussis incidence resulting from persons being up to date on pertussis-antigen containing vaccines. Bayesian techniques were used to correct for purported nondifferential misclassification by reclassifying the cases per the 2014 Council of State and Territorial Epidemiologists pertussis case definition. Naïve VE was 50% (95% confidence interval: 16%, 69%). After correcting for misclassification, VE ranged from 57% (95% credible interval: 30, 73) to 82% (95% credible interval: 43, 95), depending on the amount of underreporting of pertussis that was assumed to have occurred in the study period. Meaningful misclassification was observed in terms of false negatives detected after the incorporation of infant apnea to the 2014 case definition. Although specificity was nearly perfect, sensitivity of the case definition varied from 90% to 20%, depending on the assumption about missed cases. Knowing the degree of the underreporting is essential to the accurate evaluation of VE., (© The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The current outbreak of Ebola virus disease has mobilized the international community against this deadly disease. However, rabies, another deadly disease, is greatly affecting the African continent, with an estimated 25 000 deaths every year. And yet, the disease can be prevented by a vaccine, if necessary with immunoglobulin, even when administered after exposure to the rabies virus. Rabies victims die because of neglect and ignorance, because they are not aware of these life-saving biologicals, or because they cannot access them or do not have the money to pay for them. Breaking the cycle of indifference of rabies deaths in humans in Africa should be a priority of governments, international organizations and all stakeholders involved., (© The Author 2014. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The severe acute respiratory syndrome crisis exposed serious deficiencies in China's public health system and willingness to report outbreaks of threats to public health. Consequently, China may be one of the weak links in global preparedness for avian influenza. China's rural health care system has been weakened by 20 years of privatization and fiscal decentralization. China plays a huge role in the global poultry industry, with a poultry population of 14 billion birds, 70%-80% of which are reared in backyard conditions. Although surveillance has been strengthened, obstacles to the timely reporting of disease outbreaks still exist. The weakened health care system prevents many sick people from seeking care at a health care facility, where reporting would originate. Inadequate compensation to farmers for culled birds leads to nonreporting, and local officials may be complicit if they suspect that reporting might lead to economic losses for their communities. At the local level, China's crisis-management ability and multisectoral coordination are weak. The poor quality of infection control in many rural facilities is a serious and well-documented problem. However, traditions of community political mobilization suggest that the potential for providing rural citizens with public health information is possible when mandated from the central government. Addressing these issues now and working on capacity issues, authority structures, accountability, and local reporting and control structures will benefit the control of a potential avian influenza outbreak, as well as inevitable outbreaks of other emerging infectious diseases in China's Pearl River Delta or in other densely populated locations of animal husbandry in China.

The quality of research in hospital epidemiology (infection control) must be improved to be robust enough to influence policy and practice. In order to raise the standards of research and publication, a CONSORT equivalent for these largely quasi-experimental studies has been prepared by the authors of two relevant systematic reviews, following consultation with learned societies, editors of journals and researchers. It consists of a 22 item checklist, and a summary table. The emphasis is on transparency to improve the quality of reporting and on the use of appropriate statistical techniques. The statement has been endorsed by a number of professional special interest groups and societies. Like CONSORT, ORION should be considered a 'work in progress', which requires ongoing dialogue for successful promotion and dissemination. The statement is therefore offered for further public discussion. Journals and research councils are strongly recommended to incorporate it into their submission and reviewing processes. Feedback to the authors is encouraged and the statement will be revised in 2 years.

Background: As infection with vancomycin-resistant enterococci (VRE) increases in hospitals, knowledge about VRE reservoirs and improved accuracy of epidemiologic measures are needed. Many assessments underestimate incidence by including prevalent carriers in at-risk populations. Routine surveillance cultures can substantially improve prevalence and incidence estimates, and assessing the range of improvement across diverse units is important., Methods: We performed a retrospective cohort study using accurate at-risk populations to evaluate the range of benefit of admission and weekly surveillance cultures in detecting unrecognized VRE in 14 patient-care units., Results: We assessed 165 unit-months. The admission prevalence of VRE was 2.2%-27.2%, with admission surveillance providing 2.2-17-fold increased detection. Medical units were significantly more likely to admit VRE carriers than were surgical units. Monthly incidence was 0.8%-9.7%, with weekly surveillance providing 3.3-15.4-fold increased detection. The common practice of reporting incidence using the total number of patients, rather than patients at risk, underestimated incidence by one-third. Overall, routine surveillance prevented the misclassification of 43.0% (unit range, 0%-85.7%) of "incident" carriers on the basis of clinical cultures alone and increased VRE precaution days by 2.4-fold (unit range, 2.0-2.6-fold)., Conclusions: Routine surveillance markedly increases the detection of VRE, despite variability across patient-care units. Correct denominators prevent the substantial underestimation of incidence.

Faced with expectations to improve patient safety and contain costs, the US health care system is under increasing pressure to comprehensively and objectively account for nosocomial infections. Widely accepted nosocomial infection surveillance methods, however, are limited in scope, not sensitive, and applied inconsistently. In 907 inpatient admissions to Evanston Northwestern Healthcare hospitals (Evanston, IL), nosocomial infection identification by the Nosocomial Infection Marker (MedMined, Birmingham, AL), an electronic, laboratory-based marker, was compared with hospital-wide nosocomial infection detection by medical records review and established nosocomial infection detection methods. The sensitivity and specificity of marker analysis were 0.86 (95% confidence interval [CI 95], 0.76-0.96) and 0.984 (CI 95, 0.976, 0.992). Marker analysis also identified 11 intensive care unit-associated nosocomial infections (sensitivity, 1.0; specificity, 0.986). Nosocomial Infection Marker analysis had a comparable sensitivity (P > .3) to and lower specificity (P < .001) than medical records review. It is important to note that marker analysis statistically outperformed widely accepted surveillance methods, including hospital-wide detection by Study on the Efficacy of Nosocomial Infection Control chart review and intensive care unit detection by National Nosocomial Infections Surveillance techniques.

Effective surveillance is necessary for the successful management of emerging infection. It allows public health protection measures such as contact tracing and isolation to be put in place. This study aimed to find the most appropriate surveillance method for a disease like SARS. Existing surveillance methods were evaluated against a set of new criteria in a qualitative manner. Influenza and tuberculosis (TB) surveillance were used as models. A literature search was undertaken to find relevant evidence. The results show that TB surveillance is more appropriate than influenza surveillance as a model because it is more complete in its reporting. Clinician-based reporting is better than laboratory-based because it is more timely. The results suggest a clinician-based notification system would be the most appropriate form of surveillance for a disease like SARS for public health purposes.

Despite state and local laws requiring medical providers to report notifiable infectious diseases to public health authorities, reporting is believed to be incomplete. Through means of an analytical literature review, the authors synthesize current knowledge on the completeness of disease reporting and identify factors associated with reporting completeness. The review was limited to published studies, conducted in the United States between 1970 and 1999, that quantitatively assessed infectious disease reporting completeness. Thirty-three studies met the inclusion criteria. Reporting completeness, expressed between 0% and 100%, was treated as the dependent outcome variable in statistical analysis; disease, study location, time period, study design, and study size were treated as independent variables. Fifty-six distinct measures of reporting completeness were identified for 21 diseases. Reporting completeness varied from 9% to 99% and was most strongly associated with the disease being reported. The mean reporting completeness for acquired immunodeficiency syndrome, sexually transmitted diseases, and tuberculosis as a group was significantly higher (79%) than for all other diseases combined (49%) (p < 0.01).

Notification is an important source of health information. However, it suffers from the serious limitation of under-reporting, especially in 'third world' countries. The aims of this study were to assess the impact of a special notification nurse and ward notification register on the rate of notification from a general medical unit, the knowledge and attitudes of intern medical officers regarding notification, and the community outcome of notification in a Sri Lankan setting. Overall, appointment of a special nurse improved notification rates from 9.7% to 62.1%, and the addition of a special ward notification register further improved the rate to 95.1% The results also indicated that, although a majority of intern medical officers were aware of notifiable diseases and the importance of notification, only a few of them always notified notifiable diseases. One of the main reasons given for this was that the majority of them felt that no useful action was taken on notifications by the preventive health authorities, a view that was held because there was no feedback information regarding the notifications. However, during the period of this study nearly 80% of all notifications were successfully investigated by the relevant medical officer of health office. The appointment of a nurse dedicated to notification and introduction of a ward notification register could greatly improve notification rates. Better communication between curative and preventive health sectors would improve attitudes of doctors regarding notification.