Title: National Surveillance for Paralytic Poliomyelitis and Nonparalytic Poliovirus Infection

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09-ID-53 Committee: Infectious Title: National Surveillance for Paralytic Poliomyelitis and Nonparalytic Poliovirus Infection I. Statement of the Problem CSTE position statement 07-EC-02 recognized the need to develop an official list of nationally notifiable conditions and a standardized reporting definition for each condition on the official list. The position statement also specified that each definition had to comply with American Health Information Community recommended standards to support automated case reporting from electronic health records or other clinical care information systems. In July 2008, CSTE identified sity-eight conditions warranting inclusion on the official list, each of which now requires a standardized reporting definition. II. Background and Justification Poliomyelitis is characterized by the acute onset of flaccid paralysis caused by one of the 3 types of poliovirus. The paralysis is typically asymmetric, most often affecting the lower limbs. The great majority of poliovirus infections are asymptomatic or subclinical. Fewer than 1% are paralytic. The onset of paralysis is rapid and does not progress after 3 days. Transmission is primarily by the fecal-oral route. Vaccine-associated paralytic poliomyelitis can occur in both oral poliovirus vaccine recipients and their contacts. Vaccine-derived polioviruses may circulate and cause disease. Starting in 1988, the World Health rganization targeted poliomyelitis for eradication. Polio is currently endemic in only 6 countries in Africa and South Asia. Because of the risks associated with oral poliovirus vaccine, the US and most industrialized countries are now using only inactivated poliovirus vaccine. Non-immune persons traveling outside industrialized countries are at risk of being infected with either wild-type or vaccine-derived polioviruses. Until polio is eradicated and oral poliovirus vaccine use has been stopped worldwide, there is a risk that imported polioviruses may circulate and cause disease in populations with low immunization coverage. Wild poliovirus transmission has been eliminated from the Americas since 1991. For this reason, two conditions are nationally notifiable: paralytic poliomyelitis, in which clinical criteria for the disease have been met; and non-paralytic poliovirus infection, in which the case-patient is asymptomatic or mildly ill without paralysis. Furthermore, because oral polio vaccine has not been recommended in the United States since 2000 and has been unavailable in the United States since about 2002, and because vaccine-derived polioviruses can circulate in unvaccinated communities and revert to wild poliovirus phenotype, suspected cases of paralytic poliomyelitis or non-paralytic poliovirus infection should be reported and notified immediately, regardless of whether the virus is suspected to be wild poliovirus or vaccine-derived poliovirus. Page 1 of 9

Paralytic poliomyelitis and non-paralytic poliovirus infection meet the definition of a nationally and immediately notifiable condition as specified in CSTE position statement 08-EC-02 for the following reason(s): The conditions have special importance for international health regulations (IHR). The conditions or diseases have been declared eliminated (absence of endemic disease transmission) in the United States. A majority of state and territorial jurisdictions or jurisdictions comprising a majority of the US population have laws or regulations requiring immediate reporting of the conditions to public health authorities; the Centers for Disease Control and Prevention (CDC) requests immediate notification of the conditions; and the CDC has condition-specific policies and practices concerning its response to and use of notifications. III. Statement of the desired action(s) to be taken CSTE requests that states adopt this standardized reporting definition and CDC adopt these standard notification criteria for paralytic poliomyelitis and nonparalytic poliovirus infection to facilitate more timely, complete, and standardized local and national reporting of this condition. IV. Goals of Surveillance To rapidly identify and contain any importations into the United States of wild or vaccinederived poliovirus. V. Methods for Surveillance Surveillance for paralytic poliomyelitis and nonparalytic poliovirus infection should use the sources of data and the etent of coverage listed in Table V. Table V. Recommended sources of data and etent of coverage for ascertaining cases of Paralytic Poliomyelitis and Nonparalytic Poliovirus Infection Coverage Source of data for case ascertainment clinician reporting laboratory reporting reporting by other entities (e.g., hospitals, veterinarians, pharmacies) death certificates hospital discharge or outpatient records etracts from electronic medical records telephone survey school-based survey other Population-wide Sentinel sites Page 2 of 9

VI. Criteria for Reporting Reporting refers to the process of healthcare providers or institutions (e.g., clinicians, clinical laboratories, hospitals) submitting basic information to governmental public health agencies about cases of illness that meet certain reporting requirements or criteria. The purpose of this section is to provide those criteria to determine whether a specific illness should be reported. A. Narrative description of criteria to determine whether a case should be reported to public health authorities Report any illness to public health authorities that meets any of the following criteria: For Paralytic Poliomyelitis Acute onset of flaccid paralysis in a person o for whom any of the indicated lab tests listed below have been ordered; Culture for poliovirus Acute and convalescent serum anti-polio IgG antibodies R o who has any of the epidemiologic risk factors listed below: Resident of or international travel to country using PV in past 30 days Receipt of oral polio vaccine in last 30 days Contact with person who has received oral polio vaccine in the last 75 days 0 doses of polio vaccine (IPV or PV) For Nonparalytic Poliovirus Infections Any case in a person o from whom culture of a clinical specimen for poliovirus has been ordered; or o from whom poliovirus has been isolated. ther recommended reporting procedures All cases of paralytic poliomyelitis and nonparalytic poliovirus infection should be reported. Reporting should be immediate. All suspected cases of paralytic poliomyelitis should be reviewed by a panel of epert consultants before final classification occurs. Page 3 of 9

B. Table of criteria to determine whether a case should be reported to public health authorities Table VI-B. Table of criteria to determine whether a case should be reported to public health authorities. Requirements for reporting are established under State and Territorial laws and/or regulations and may differ from jurisdiction to jurisdiction. These criteria are suggested as a standard approach to identifying cases of this condition for purposes of reporting, but reporting should follow State and Territorial law/regulation if any conflicts occur between these criteria and those laws/regulations. Criterion Clinical Evidence Reporting Acute onset, flaccid paralysis N N Laboratory Evidence Isolation of poliovirus from a clinical specimen rder of a culture for poliovirus S rder for acute and convalescent serum anti-polio IgG antibodies Epidemiologic Evidence Resident of or international travel to country using PV in past 30 days Receipt of oral polio vaccine in last 30 days Contact with person who has received oral polio vaccine in the last 75 days 0 doses of polio vaccine (IPV or PV) Notes: S = This criterion alone is Sufficient to identify a case for reporting. N = All N criteria in the same column are Necessary to identify a case for reporting. = At least one of these (ptional) criteria in each category (i.e., clinical evidence and laboratory evidence) in the same column in conjunction with all N criteria in the same column is required to identify a case for reporting. (These optional criteria are alternatives, which means that a single column will have either no criteria or multiple criteria; no column should have only one.) C. Disease Specific Data Elements: Disease-specific data elements to be included in the initial report are listed below. Clinical Criteria Paralysis, date of onset Asymmetric paralysis Ascending paralysis S Page 4 of 9

Immune deficiency, any EMG test result Nerve conduction velocity test results Epidemiological Risk Factors Countries visited in last 30 days Number of PV doses received Date of last PV dose Number of IPV doses received Contact with a person who has received PV in last 75 days Contact with a person diagnosed with polio or poliovirus infection VII. Case Definition for Case Classification A. Narrative description of criteria to determine whether a case should be classified as confirmed or probable paralytic poliomyelitis or non-paralytic poliovirus infection: Comment 1. Paralytic poliomyelitis Probable: Acute onset of a flaccid paralysis of one or more limbs with decreased or absent tendon reflees in the affected limbs, without other apparent cause, and without sensory or cognitive loss. Confirmed: Acute onset of a flaccid paralysis of one or more limbs with decreased or absent tendon reflees in the affected limbs, without other apparent cause, and without sensory or cognitive loss; AND in which the patient has a neurologic deficit 60 days after onset of initial symptoms; or has died; or has unknown follow-up status. 2. Nonparalytic poliovirus infection Confirmed: Any person without symptoms of paralytic poliomyelitis in whom a poliovirus isolate identified in an appropriate clinical specimen (e.g., stool, cerebrospinal fluid, oropharyngeal secretions), with confirmatory typing and sequencing performed by the CDC Poliovirus Laboratory, as needed. All suspected cases of paralytic poliomyelitis are reviewed by a panel of epert consultants before final classification occurs. Confirmed cases are then further classified based on epidemiologic and laboratory criteria (11). nly confirmed cases are included in Table I in the MMWR. Suspected cases are enumerated in a footnote to the MMWR table. Page 5 of 9

B. Classification Tables Table VII-B lists the criteria that must be met for a case to be classified as confirmed or probable (presumptive) poliomyelitis or a non-paralytic poliovirus infection. Table VII-B. Table of criteria to determine whether a case is classified. Criterion Clinical Evidence Acute onset, flaccid paralysis in one or more limbs Decreased or absent tendon reflees in the affected limbs Case Definition Paralytic Poliomyelitis Non-paralytic Poliovirus Infection Confirmed Probable Confirmed N N N N N N No sensory deficit N N N No cognitive deficit N N N Paralysis present 60 days after onset of initial symptoms Death Follow-up status unknown ther apparent cause of paralysis (e.g., trauma to affected limb, spinal cord injury) Laboratory Evidence A A A Isolation of poliovirus from a clinical S specimen Notes: S = This criterion alone is Sufficient to classify a case. N = All N criteria in the same column are Necessary to classify a case. A = This criterion must be absent (i.e., NT present) for the case to meet the classification criteria. = At least one of these (ptional) criteria in each category (i.e., clinical evidence and laboratory evidence) in the same column in conjunction with all N criteria in the same column is required to classify a case. VIII. Period of Surveillance Surveillance should be on-going. Page 6 of 9

IX. Data sharing/release and print criteria Notification to CDC for confirmed cases of polio is recommended. Data reported to NCIRD staff is summarized weekly internally via an NCIRD weekly surveillance report for vaccine preventable diseases. Electronic reports of cases of paralytic poliomyelitis and nonparalytic poliovirus Infection in NNDSS are also summarized weekly in the MMWR Tables. However, because of delays in data entry and data transmission via NNDSS, these two data sources may not correspond. Annual case data on polio is also summarized in the yearly Summary of Notifiable Diseases. State-specific compiled data will continue to be published in the weekly and annual MMWR. In addition to those reports, the frequency of reports/feedback to the states and territories will be dependent on the current epidemiologic situation in the country. Frequency of cases, epidemiologic distribution, importation status, transmission risk, and other factors will influence frequency and method of communication and information feedback. State-specific compiled data will continue to be published in the weekly reports and annual MMWR Surveillance Summaries. All cases are verified with the state (s) before publication. Data are also included in PAH and WH annual reports The frequency of release of additional publication of this data will be dependent on the current epidemiologic situation in the country. These publications might include annual epidemiologic summaries in the MMWR or manuscripts in peer-reviewed journals. As part of an effort to document polio elimination in the Americas, we currently report data on all suspect cases of polio known to NCIRD to PAH on a weekly basis. Information on se, age, rash onset, vaccination status, genotype and source (import, import-associated etc.) is provided. No personal identifying or state specific information is re-released to PAH or WH. Page 7 of 9

X. References Centers for Disease Control and Prevention (CDC). Case definitions for infectious conditions under public health surveillance. MMWR 1997;46(No. RR-10):1 57. Available from: http://www.cdc.gov/mmwr/ Centers for Disease Control and Prevention (CDC). National notifiable diseases surveillance system: case definitions. Atlanta: CDC. Available from: http://www.cdc.gov/ncphi/disss/nndss/casedef/inde.htm Last updated: 2008 Jan 9. Accessed: Council of State and Territorial Epidemiologists (CSTE). CSTE official list of nationally notifiable conditions. CSTE position statement 07-EC-02. Atlanta: CSTE; June 2007. Available from: http://www.cste.org. Council of State and Territorial epidemiologists (CSTE). Revised Case Definitions for Public Health Surveillance: Infectious Disease 1996-18. Atlanta: CSTE; 1996. Available from http://www.cste.org. Council of State and Territorial Epidemiologists (CSTE). Criteria for inclusion of conditions on CSTE nationally notifiable condition list and for categorization as immediately or routinely notifiable. CSTE position statement 08-EC-02. Atlanta: CSTE; June 2008. Available from: http://www.cste.org. Council of State and Territorial Epidemiologists, Centers for Disease Control and Prevention. CDC-CSTE Intergovernmental Data Release Guidelines Working Group (DRGWG) Report: CDC-ATSDR Data Release Guidelines and Procedures for Re-release of State-Provided Data. Atlanta: CSTE; 2005. Available from: http://www.cste.org/pdffiles/2005/drgwgreport.pdf or http://www.cdc.gov/od/foia/policies/drgwg.pdf. Heymann DL, editor. Control of communicable diseases manual. 18th edition. Washington: American Public Health Association; 2004. Modlin JF. Poliovirus. In: Mandell GL, Bennett JE, Dolin R, editors. Principles and Practice of Infectious Diseases, 6th edition. Philadelphia: Churchill Livingstone; 2005. Page 8 of 9

XI. Coordination: Agencies for Response: (1) Thomas R Frieden, MD, MPH Director Centers for Disease Control and Prevention 1600 Clifton Road, NE Atlanta GA 30333 (404) 639-7000 tf2@cdc.gov XII. Submitting Author: (1) Paul Cieslak, MD Manager, Acute and Communicable Disease Prevention regon Department of Human Services 800 NE regon St./Suite 772 Portland, R 97232 (971) 673-1111 paul.r.cieslak@state.or.us Co-Authors: (1) Associate Member Harry F. Hull, Medical Epidemiologist HF Hull & Associates, LLC 1140 St. Dennis Court Saint Paul, MN 55116 (651) 695-8114 hullhf@msn.com (2) Associate Member Cecil Lynch, Medical Informaticist ntoreason 7292 Shady Woods Circle Midvale, UT 84047 (916) 412.5504 clynch@ontoreason.com (3) Associate Member R. Gibson Parrish, Medical Epidemiologist P.. Bo 197 480 Bayley Hazen Road Peacham, VT 05862 (802) 592-3357 gib.parrish@gmail.com Page 9 of 9