A Global Patient Registry for Human Avian Influenza
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1 A Global Patient Registry for Human Avian Influenza Understanding Clinical Presentation, Treatment Outcomes, and Survival Introduction September, 2008 Human Avian Influenza represents a major concern for public health globally. It is believed to have the potential to lead to a global flu outbreak that could lead to many thousands of deaths similar to historical influenza pandemics. In order to establish a first-line scientific and medical response to this threat, a global patient registry has been developed to assist health care professionals and governments to respond based on accurate and current information. The first phase of this registry was launched in several key countries to verify its scope, applicability, reporting, and efficiency. The Avian/Pandemic Flu Registry is an international, on-line observational research effort that uniquely collects information regarding symptoms, diagnosis, treatments, and outcomes of patients affected by human avian influenza. The registry makes it possible for experts to evaluate data and to understand the epidemiology and health consequences of the spread of the disease, and to assess the effectiveness of various interventions. This partnership in data gathering and the pooling of expertise allows real-time aggregated reports to be shared with national and international health agencies, as pre-determined by those submitting data, along with other organizations interested in preventing or mitigating an outbreak of pandemic influenza. Project Description The registry has been developed and implemented as a public health tool with uses and ports of entry for both public and private organizations sharing an interest in disease recognition and prevention. The goal of the registry is to improve understanding of the clinical course of Human Avian Influenza, an acute, potentially highly communicable, and often fatal infectious disease with significant public health and pandemic implications. The registry collects information on clinical presentation, all treatments, clinical course and outcome for human patients who are suspected to have been infected with avian influenza strains (see table on page 4.) Data are collected both for laboratory-supported cases and for cases that are suspected to be avian influenza but for which there is no laboratory confirmation. Public health and infectious disease professionals work within their countries to identify and include diagnostic, clinical, treatment, and outcomes patient data that may be available from existing records and from medical personnel who have may have treated cases of avian influenza. All data are collected and analyzed in an observational framework. No human experimentation is involved (e.g., there are no clinical trials). All cases believed to have avian Avian/Pandemic Flu Registry Page 1 of 5
2 influenza are eligible for inclusion in the registry. In addition, information is sought on patients with documented seroconversion, who either remain asymptomatic or experience only mild illness. The Project Tool Data are collected both through abstraction of information from medical records onto case report forms, and in real time as new cases emerge. The project recognizes that not all of the desired data will be available. Nonetheless, as the project develops it intends to work also as a tool to assist medical staff in identifying and accurately reporting some key information about cases of human avian flu. As new cases arise it is expected that the countries that have already reported cases to the registry will be better positioned to receive aggregated current, accurate and complete information as reported through local treating physicians or other health care personnel. Case reporters working with national partner registries may enter the data through a direct webbased data entry portal or they may choose to first collect the information on paper-based case report forms. The completed case report forms are then uploaded to the registry, either by fax or by direct data entry through the web. The data are reviewed at the central registry and any data queries are addressed through standard operating procedures developed in collaboration with the national partners. Ethical Considerations Data collected using the case report forms do not include patient names or addresses, but do include relevant demographic information. One of the goals of the project is that the data will be sufficient to allow eventual linkage by public health authorities to gene databases for general treatment and public health purposes. Nonetheless, the project is aware that due to the very limited number of cases that have occurred, it is possible that some patients may be recognizable even with the limited amount of information presented; indeed, some patients have had their names published in the lay press. Thus a number of ethical issues need to be addressed by each of the partners, and collectively, during the implementation of this registry. Several ethical reviews have taken place, and approvals have been received. National Benefit and Global Cooperation The national registries have direct access to all data from their country as well as access through the central registry to aggregate reports of the globally reported cases. The on-line system allows ministries of health and other participants to have immediate access to current information from their own country on treatments that were used, including timing of treatment initiation, dosing, duration of use, and survival. Authorized persons from partner countries will also have access to the central registry to evaluate global trends and developments related to avian influenza. Strong data protection and security measures have been developed to protect the integrity of the Avian/Pandemic Flu Registry Page 2 of 5
3 data as well as to ensure that patient and national confidential information is not breached. Data collection is facilitated by national partners trained in the data collection tool. Initially the data will be collected and stored in the English language. As the registry develops, interfaces may be developed to facilitate data collection in other major international languages (for example, Malay, Thai, Vietnamese, Russian, Chinese, Arabic, Turkish, Spanish, French, etc.) The Central Registry The central registry has been developed by Outcome Sciences, Inc., an independent entity with offices in Morges, Switzerland and Cambridge, Massachusetts, with sponsorship from Hoffman- La Roche, the manufacturer of Tamiflu. The project has been discussed with many agencies including the World Health Organization, and has benefited from numerous experts. The role of the central registry is to assist with the implementation and development of national registries, to develop common objectives and standard operating procedures, to assist with the initial training of data reporters in the different countries, and to ensure the security, integrity, and ongoing validity of the data stored in the registry. The registry has been designed and is being operated with formalized governance that establishes the rights and roles of collaborators including financial sponsors. The registry design and procedures are consistent with established guidelines for assuring the quality of observational registries. Summary The Avian/Pandemic Flu Registry is an international observational study of how human cases of avian influenza are diagnosed and treated in actual practice taking into account outcomes in those cases. This project is designed as a collaborative study involving members of national public health authorities and health care associations. The project will develop a focal point for the international scientific and medical communities interested in better understanding the clinical course and effectiveness of current treatments for avian influenza. The study does not recommend any specific diagnostic or treatment method, but hopes that the collected data will yield insight for national and public health authorities when making diagnostic and treatment decisions regarding avian influenza. These data may further be useful in guiding decisions on the allocation of resources and will serve as an important, multi-country centralized information source for identifying the evolving characteristics of typical and atypical patient presentation and treatment effectiveness in the event of a pandemic. Avian/Pandemic Flu Registry Page 3 of 5
4 Table: Overview of Data Collection Initial Presentation, Clinical Course, Treatment, Outcome Data are collected on six forms, depending on data availability: PRIMARY FORM: Basic case reporting for essential and frequently-documented information MEDICATION FORM: Details of all medications given for treatment or prophylaxis, includes information on dose, frequency, duration, and treatment outcome VIRAL TESTING FORM: Results of viral testing, and record of past influenza vaccination LABORATORY TESTING FORM: Results of laboratory testing done EXTENDED FORM: More detailed information, including extensive symptoms and clinical course SYMPTOM RECURRENCE: Used for repeat medical encounters in patients who appear to recover but experience a recurrence of symptoms. Similar in content to primary/extended forms. PRIMARY CASE REPORT SOURCE Name Occupation Contact Information Type of source DEMOGRAPHY Age Weight Gender Locale Presentation location (clinic, ER, etc) RELEVANT EXPOSURE Type and date of exposure within 7 days Consumption, handling, human, lab sample INFLUENZA SYMPTOMS Date of overall symptom onset Predominant symptom type at presentation GENERAL CASE ASSESSMENT Lab-supported/likely/unlikely PATIENT OUTCOME Alternative diagnosis (misdiagnosis) Recovered with or without major sequelae Death Outcome unknown to reporter MEDICATIONS & OXYGEN USE EXTENDED PRE-EXISTING MEDICAL CONDITIONS Respiratory Immunodeficiency Neurological disorder Pregnancy Renal failure, CHF SPECIFIC SYMPTOM DETAILS Fever Upper respiratory tract Gastrointestinal Neurological or psychiatric Other signs and symptoms CLINICAL COURSE Hospitalization Organ failure Sepsis Pneumonia/pulmonary infiltrates Renal dysfunction/failure ABNORMAL ENZYME LEVELS ALT/SGPT LDH Other Liver Function Total CPK VIRAL TESTING Avian/Pandemic Flu Registry Page 4 of 5
5 ANTIVIRALS ANTIBIOTICS ANTIPYRETICS/NSAIDS CORTICOSTEROIDS OTHER PRESCRIPTION OXYGEN USE Supplemental Oxygen Invasive mechanical ventilation Non-invasive mechanical ventilation VIRAL TESTING Influenza laboratory results: type of test, date of test, where test performed Viral Subtype Viral Genotype Presence of neuraminidase mutations Viral Load Phenotypic Sensitivity Testing PRIOR INFLUENZA VACCINATIONS Receipt of influenza vaccine in the past year Date of vaccination Vaccine product name Liver Function Renal Function Blood Counts Electrolytes Arterial blood gases Acute phase proteins Other LABORATORY TESTING For more information, please contact: Dr. Nancy A. Dreyer Project Director Outcome Sciences, Inc. Direct Tel: Skype: nadreyer Avian/Pandemic Flu Registry Page 5 of 5
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