Should This Event Be Notified to the World Health Organization? Reliability of the International Health Regulations Notification Assessment process/Cet Evenement Doit-Il Etre Notifie a l'Organisation Mondiale De la Sante? Fiabilite Du Processus D'evaluation De la Notification Du Reglement Sanitaire international/?Deberia Notificarse Este Suceso a la Organizacion Mundial De la Salud?

Introduction The International Health Regulations (2005) (IHR), which entered into force in June 2007, are a legally binding agreement between 194 States Parties, including states that are not Member States of the World Health Organization (WHO). (1) Under the IHR, States Parties are required to notify WHO of "all events which may constitute a public health emergency of international concern". Whether a given event is notifiable is determined using an algorithm: the decision instrument contained in Annex 2 of the IHR. (1) The decision instrument defines an event as notifiable if it satisfies two or more of the following four criteria: (i) the event has a serious public health impact; (ii) the event is unusual or unexpected; (iii) there is a significant risk of international spread; (iv) there is a significant risk of international travel or trade restrictions. In addition, all cases of smallpox, wild-type polio, novel-subtype human influenza virus infection and severe acute respiratory syndrome (SARS) are "intrinsically" notifiable, without the need to apply the four criteria. Annex 2 of the IHR is designed to heighten the sensitivity of the notification process and thus ensure a timely assessment of and response to critical public health events. (2) The IHR stipulate that each State Party designate an office with which WHO can communicate at all times: the National IHR Focal Point (NFP). The NFPs receive guidance and training from WHO. (2-6) They are responsible for contacting WHO about notifiable events and WHO recommends that they coordinate the notification assessment process, though they may not themselves be responsible for actually assessing the public health risk. (3) Article 54.3 of the IHR, (1) as well as World Health Assembly resolutions 58.37 and 61.2, (8) mandate WHO to conduct studies to review and evaluate the functioning of Annex 2 of the IHR. A 2008 WHO technical consultation recommended that an assessment be carried out to evaluate agreement among NFPs when judging certain described events using Annex 2. (9) The University of Geneva Hospitals' Infection Control Programme in Switzerland was commissioned to carry out this assessment. Methods Survey design The survey exploring NFPs' use of Annex 2 of the IHR was based on several fictitious scenarios that described events devised to represent a wide range of public health risks with a varying likelihood of being considered notifiable. The number of scenarios included was limited to 10 and the vignettes (Box 1) were kept succinct to minimize the time and effort required from participants and to maximize the response rate. Box 2 provides summaries of the 10 scenarios. For each scenario, six items about the notifiability of the event had to be answered either "yes", "no" or "don't know" (Table 1). These items were: the personal opinion of the individuals who responded on behalf of the NFPs about whether the event was notifiable (item 1); the NFP's judgement of whether each of the four criteria of the decision instrument in Annex 2 were satisfied (items 2-5); and the NFP's judgement of whether an actual notification decision under the IHR should be made (item 6). The structure of the survey required participants to go through all four criteria for each scenario, including scenario 7, which described an intrinsically notifiable event (i.e. a case of wild-type polio). Survey implementation The survey was made available in the six languages used by the World Health Assembly via a secure web site (available at: https://www.surveymonkey.com/s.asp x?sm=GX8_2f9IUtDrEbMrNQpAFy lg_3d_3d) and a printable version was provided on request. All 193 NFPs for which WHO had e-mail addresses were invited to participate by the University of Geneva Hospitals' Infection Control Programme. Each State Party could submit only one completed survey. Access to the web survey was achieved by individualized links, which ensured that responses could be correctly attributed to a specific State Party. …