The Who Stepwise Approach To Stroke Surveillance

The WHO STEPwise approach to stroke surveillance
WHO STEPS Stroke Manual
WHO Library Cataloguing-in-Publication Data: WHO STEPS Stroke Manual: the WHO STEPwise approach to stroke surveillance / Noncommunicable Diseases and Mental Health, World Health Organization. 1. Cerebrovascular accident - epidemiology. 2. Epidemiologic surveillance - methods. 3. Manuals. I. World Health Organization. ISBN 92 4 159404 7 (NLM classification: WT 355)
World Health Organization 2005 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Suggested citation: World Health Organization (2006). WHO STEPS Stroke Manual: The WHO STEPwise approach to stroke surveillance. Geneva, World Health Organization. Acknowledgements: STEPS Stroke is a collaborative effort between WHO and Non Governmental Organizations (NGOs), notably the International Stroke Society (ISS), the major stroke NGO in official relations with WHO. The Board of the ISS, under the direction of Julian Bogousslavsky, Bo Norrving and Frank Yatsu, has maintained a close interest in the development of surveillance of stroke as part of a broader global stroke initiative. Ruth Bonita chairs the WHO-ISS International Stroke Surveillance Coordinating Unit. The Stroke surveillance Manual was produced by Ruth Bonita, Peter Heuschmann and Thomas Truelsen. Information Mapping of the manual was undertaken by Charlotte Mill. The Data Entry Tool was developed by the Institute of Epidemiology and Social Medicine, University of Munster, Germany. This WHO Collaborating Centre also provides overall responsibility for data management. Valuable input and suggestions were provided by the Principal Investigators of the feasibility study undertaken to test the materials in country surveillance sites: Dr Airian, Moscow, Russia; Dr. Dalal, for ICASS centres, India; Dr. Damasceno, Maputo, Mozambique; Dr. Nagaraja, Bangalore, India; Dr. Ogunniyi, Ibadan, Nigeria; Dr. Oveisgharan, Isfahan, Iran; Dr. Pandiyan, Chennai, India; Dr Radhakrishnan Trivandrum, India; Dr. Skvortsava Moscow, Russia. The WHO Regional Advisers and the WHO STEPS Surveillance team are acknowledged for their input into and production of the STEPS surveillance tools (http://www.who.int/chp/steps). Support from the Australian Stroke Society, Canadian Stroke Consortium, European Stroke Conference, Japan Stroke Society, Kenes, Taiwan Stroke Society, the World Federation of Neurology, the World Heart Federation, the World Stroke Federation, and the Government of Finland is also gratefully acknowledged. The STEPS STROKE Manual can be downloaded at http://www.who.int/chp/steps/Stroke/en/
Table of Contents
SECTION 1: INTRODUCTION Overview ...................................................................................................... 1-1 Rationale for Stroke Surveillance ................................................................ 1-2 About Stroke ................................................................................................ 1-4 Major Risk Factors ....................................................................................... 1-8 In-hospital Management and Facilities ........................................................ 1-9 Overview of STEPS Stroke........................................................................ 1-10 Key Definitions and Concepts ................................................................... 1-12 Setting Objectives ..................................................................................... 1-13 Stroke Surveillance Process Overview ...................................................... 1-14
SECTION 2: ROLES AND RESPONSIBILITIES Overview ...................................................................................................... 2-1 Site Coordinator ........................................................................................... 2-2 Site Data Collection Staff............................................................................. 2-3 International Coordinating Unit ................................................................... 2-4 International Advisory Group ...................................................................... 2-6 SECTION 3: PLANNING AND PREPARING A STROKE STUDY Overview ...................................................................................................... 3-1 Process Overview and Eligibility................................................................. 3-2 Identifying the Scope ................................................................................... 3-3 Defining the STEPS Stroke Surveillance Site.............................................. 3-5 Identifying the Study Population.................................................................. 3-7 Modifying the Stroke Instrument ............................................................... 3-10 Applying for Participation.......................................................................... 3-12 Getting Ethical Approval ........................................................................... 3-13
SECTION 4: PREPARING THE STROKE SURVEILLANCE SITE Overview ...................................................................................................... 4-1 Recruiting Staff ............................................................................................ 4-2 Briefing and Training for Data Collection Staff .......................................... 4-3 Setting up the Stroke Surveillance Site ........................................................ 4-4 Installing and Preparing the Data Entry Tool............................................... 4-5 Test Run ....................................................................................................... 4-7
Continued on next page
STEPS Stroke Surveillance Manual (V2.1) 2006-05-09
TOC 1
Table of Contents, Continued
SECTION 5: DATA COLLECTION GUIDELINES Overview ........................................................................................................5-1 Case Finding Methods....................................................................................5-2 Identifying Stroke Patients in Hospitals (Step 1) ...........................................5-3 Identifying Fatal Stroke Patients in the Community (Step 2) ........................5-5 Estimating Non-Fatal Stroke Events in the Community (Step 3) ..................5-7 Interview Skills ..............................................................................................5-9 Recording Responses for Registration .........................................................5-11 Completing the Stroke Instrument ...............................................................5-12 Guide to Completing All Stroke Events.......................................................5-13 Guide to Completing Step 1: Events Admitted to Hospital .........................5-15 Guide to Completing Step 2: Fatal Community Events...............................5-22 Guide to Completing Step 3: Non-Fatal Community Events.......................5-22 SECTION 6: DATA ENTRY AND DATA MANAGEMENT Overview ........................................................................................................6-1 Data Entry ......................................................................................................6-2 Data Management ..........................................................................................6-5 Creating Reports.............................................................................................6-7 Exporting Data ...............................................................................................6-8
SECTION 7: STEPS STROKE INSTRUMENT AND FORMS STEPS Stroke Instrument............................................................................. 7a-1 Application for Participation........................................................................7b-1 SECTION 8: GLOSSARY AND REFERENCE MATERIAL Glossary of Terms Used in STEPS Stroke.....................................................8-2 Source Publications and References ..............................................................8-3
STEPS Stroke Surveillance Manual (V2.1) 2006-05-09
TOC 2
Section 1: Introduction Overview
Introduction
This section is an introduction to the STEPS Stroke Surveillance Manual.
Purpose
The purpose of the manual is to provide guidelines and supporting material for sites embarking on a STEPS stroke surveillance study, so they are able to: plan and prepare the surveillance study scope and environment recruit and train data collection staff establish and maintain the stroke register report and disseminate the results.
Intended audience
The manual is primarily intended for the stroke surveillance site principal investigator. Parts of the manual are also intended for data collection staff.
Guide to using the manual
The manual has been written in modular parts and is structured to follow the sequence of events required to implement a STEPS Stroke study. It is divided into eight sections. Each section is introduced with a table of contents to help readers find specific topics. The manual includes both general information and specific instructional material that can be extracted and used for: training data collection data entry Page numbers have two components. The first number refers to the section and the second to the page number in that section. For example: 3-6 indicates section 3, page 6.
In this section
This section contains the following topics: Topic Rationale for Stroke Surveillance About Stroke Major Risk Factors In-hospital Management and Facilities Overview of STEPS Stroke Key Definitions and Epidemiological concepts Setting Objectives Stroke Surveillance Process Overview See Page 1-2 1-4 1-8 1-9 1-10 1-12 1-13 1-14
Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006
1-1 STEPS Stroke Surveillance
Rationale for Stroke Surveillance
Introduction
Well-conducted stroke surveillance (with accurate and complete registers) provides essential data that can be used to improve appropriate allocation of health resources.
Definition of surveillance
Surveillance is the ongoing, systematic: collection analysis interpretation, and dissemination of health information.
Purpose of STEPS stroke surveillance
The purpose of the WHO STEPS stroke surveillance study is to provide health workers and policy makers with a standardized tool to: assess the magnitude of stroke describe populations at risk identify associated risk factors monitor trends over time provide the basis for designing and implementing interventions monitor and evaluate the effectiveness of interventions.
The evidence
Globally, cerebrovascular disease (stroke) is the second leading cause of death. It is a disease that predominantly occurs in mid-age and older adults. WHO estimated that in 2005, stroke accounted for 5.7 million deaths world wide, equivalent to 9.9 % of all deaths. Over 85% of these deaths will have occurred in people living in low and middle income countries and one third will be in people aged less than 70 years.
Rationale for surveillance
While many countries struggle with the consequences and problems of communicable diseases, chronic noncommunicable diseases are on the rise. In addition to being a major cause of death, many surviving stroke patients are disabled and need help in activities of daily living, which must be provided by family members, the health system, or other social institutions. Lack of data on stroke from many countries hampers efficient coordination of stroke prevention, treatment, and rehabilitation. Due to future demographic changes, strategies to reduce future stroke burden and ensure adequate health resources are urgently needed. WHO STEPS stroke surveillance provides the framework for data collection and comparisons between and within populations.
Rationale for Stroke Surveillance, Continued
Other expected outcomes
Other expected outcomes of setting up surveillance sites include: Building expertise and high quality systems for long-term community surveillance of chronic noncommunicable diseases, especially stroke Establish a research network Increase awareness of noncommunicable disease in the community. Establish country-specific priorities for the prevention and management of stroke in the context of national integrated plans for chronic disease prevention and control (see http://www.who.int/chp/chronic_disease_report)
Surveillance: key to prevention
Above all, clinical trials and epidemiological studies have shown that stroke to a large extent is preventable. Public actions to lower the prevalence of exposure to risk factors, however, are unlikely to be taken, if the magnitude and consequences of stroke and other major chronic diseases are not identified.
Prevention strategies
Once reliable data are available, different prevention strategies can be implemented to reduce the occurrence and impact of stroke as described in the table below: Prevention strategy Primary Aimed at reducing.. Occurrence of stroke in the first place. For example, through.. Identification of individuals at high overall risk of stroke or CVD (hypertensive people or diabetics) Population wide initiatives to increase physical activity Legislation to control tobacco use. Intensified reduction in exposure to major cardiovascular risk factors Anti platelets and antihypertensive treatment. Treatment of infections in the acute stage Management of comorbidities Improved rehabilitation.
Secondary
Impact of stroke in people who already suffer from a stroke or TIA. Consequences and damages in stroke patients.
Tertiary
About Stroke
Introduction
Stroke is a clinically defined disease making it possible to capture data and follow trends in incidence or hospital admission rates in many different countries irrespective of access to technological equipment.
A costly disease
Stroke is a costly disease because of the: Large numbers of premature deaths, Ongoing disability in many survivors, Impact on families or caregivers and Impact on health services.
Standard WHO definition
The recommended standard WHO stroke definition is as follows: A focal (or at times global) neurological impairment of sudden onset, and lasting more than 24 hours (or leading to death), and of presumed vascular origin. This clinical definition has four components: A neurological impairment or deficit of Sudden onset, and Lasting more than 24 hours (or leading to death), and Of presumed vascular origin.
Notes on the standard definition
The WHO standard definition excludes: Transient ischemic attack (TIA), which is defined as focal neurological symptoms but lasting less than 24 hours Subdural haemorrhage Epidural haemorrhage poisoning Symptoms caused by trauma. Global refers to patients with Subarachnoid haemorrhage or deep coma but excludes coma of systemic vascular origin such as: Shock Stokes-adams syndrome Hypertensive encephalopathia. Stroke is a clinical diagnosis and not based on radiological findings
About Stroke, Continued
Types of stroke
There are three major stroke sub groups as follows: Ischemic stroke Intracerebral haemorrhage Subarachnoid haemorrhage.
Type Ischemic stroke
Intracerebral haemorrhage
Caused by Sudden occlusion of arteries supplying the brain. Due either to a thrombus formed: Directly at the site of occlusion (thrombotic ischemic stroke), or In another part of the circulation, which follows the blood stream until it obstructs arteries in the brain (embolic ischemic stroke). Bleeding from one of the brains arteries into the brain tissue. Note: May be more prevalent in developing countries possibly due to diet, physical activity, insufficient treatment of raised blood pressure, and genetic predisposition. Arterial bleeding in the space between the two meninges, pia mater and arachnoidea. Note: Typical symptoms are sudden onset of very severe headache and usually impaired consciousness.
Diagnosis based on Neuro imaging recordings Note: it may not be possible to decide clinically or radiological whether it is a thrombotic or embolic ischemic stroke. Neuro imaging recordings
Subarachnoid haemorrhage
Neuro imaging, or Lumbar puncture.
Note: Each type differs with respect to survival and long-term disability.
General major symptoms
Symptoms should be of a presumed vascular origin and should include one or more of the following definite focal or global disturbances of the cerebral function: Unilateral or bilateral motor impairment (including lack of coordination) Unilateral or bilateral sensory impairment Aphasia/dysphasia (non-fluent speech) Hemianopia (half-sided impairment of visual fields) Forced gaze (conjugate deviation) Apraxia of acute onset Ataxia of acute onset Perception deficit of acute onset.
Other symptoms
Other symptoms that may be present but are not adequate for stroke diagnosis (often resulting from other diseases or abnormalities such as dehydration, cardiac failure, infections, dementia, and malnutrition) are as follows: Dizziness, vertigo Localized headache Blurred vision of both eyes Diplopia Dysarthria (slurred speech) Impaired cognitive function (including confusion) Impaired consciousness Seizures Dysphagia.
Subarachnoid haemorrhage
For subarachnoid haemorrhage at least one of the following must be present in addition to the general major symptoms: Recent subarachnoid hemorrhage, aneurysm or arteriovenous malformation (necropsy/autopsy). Blood in the Fissura Sylvii or between the frontal lobes or in the basal cistern or in cerebral ventricles (CT or MRI). Blood stained cerebrospinal fluid (>2 000 red blood cells per mm3), aneurysm or an arteriovenous malformation (angiography). Blood stained cerebrospinal fluid (>2 000red blood cells per mm3), also xanthochromic and intra-cerebral haemorrhage (necropsy or CT).
Stroke like symptoms
A broad range of other diseases may cause similar symptoms, for example: HIV/AIDS Tuberculosis Syphilis Intracerebral cancer. These diseases are known to be able to cause focal neurologic disturbances and thereby mimic a stroke. Attention to the development of symptoms is an important factor to consider in order to avoid other diseases being misinterpreted as vascular disease, and leading to ineffective preventive strategies.
Types of stroke events
There are four types of stroke events: Type of Defined as occurring in a person who has.. stroke event First ever First ever (also called "first in a lifetime") refers to people who have never had a stroke before. Note: Previous TIA is not considered a stroke as symptoms last less than 24 hours. There are two types of recurrent strokes: A history of a previous stroke event at some time in the past which meets the WHO definition, and A history of a new stroke event occurring more than 28 days after onset of a stroke event already registered. A stroke case who survived at least 28 days after the onset of the stroke symptoms. Died within 28 days of stroke symptom onset.
Recurrent
Non-fatal Fatal
First ever stroke events
A first ever stroke event is the same as first in a lifetime event. (see Key definitions and epidemiological concepts Section 1-12)
Recurrent stroke events
For a new episode of symptoms to be counted as a new or recurrent stroke event, general stroke criteria as defined above must be met and either: The previous event in the same arterial distribution must have occurred 29, or more days previously (by subtraction of dates), or The new event is unequivocally in a different arterial territory from a earlier one occurring 28 or fewer days previously. If a patient experiences further acute symptoms suggestive of stroke within 28 days of the onset of a first episode and in the same carotid or vertebral artery territory, this second episode is not counted as a new stroke event. Equally, if a patient experiences further acute symptoms suggestive of stroke after 28 days of the onset of a first episode, this second episode is counted as a new stroke event. Note: Each event is registered separately. This means that 2 (or more) forms will be completed for the same individual who experiences multiple new acute stroke events that meet the criteria.
Major Risk Factors
Introduction
Stroke is a multi factorial disease where a combination of risk factors, all of which do not all have to be present, will, over time, influence the subjects likelihood of suffering a stroke.
Major risk factors
The major risk factors can be divided into the following categories: Category Modifiable Risk factors Elevated blood pressure Tobacco use Physical inactivity Diet (low fruit and vegetable consumption) Heavy alcohol consumption Overweight Diabetes Passive smoking Access to medical treatment. Age Sex (eg. high age and male sex are in many populations associated with an increased risk). Family history; genetics
Environmental Non-modifiable
Other risk factors
In developed countries, diabetes mellitus as well as atrial fibrillation and other cardiac diseases are other important modifiable risk factors for ischemic stroke. The role of hypercholesteremia as risk factor for stroke is currently part of an ongoing discussion. There is evidence that lower total cholesterol levels might be associated with a decreased risk of ischemic stroke but also might be accompanied by higher rates of hemorrhagic strokes.
Key sources on information on country level risk factors
WHO has developed two major tools for collecting, displaying and analysing data on the major 8 major risk factors which are common to CVD. The STEP wise framework for surveillance of Risk Factors for chronic diseases; see website: http://www.who.int/chp/steps The Global NCD InfoBase provides biennial updates on available countrylevel risk factor data including comparable mortality estimates for stroke. See website: http://www.who.int/ncd_surveillance/infobase
In-hospital Management and Facilities
Introduction
In-hospital management refers to stroke patients admitted to a health facility.
Specialist stroke teams
Stroke patients admitted to a hospital department with a specialized stroke team or multi-disciplinary approach have a better outcome than patients admitted to departments without such teams or approach. This is measured in terms of long term reduction of death, and of dependency and institutionalisation. Early rehabilitation and early mobilization of patients with severe neurological deficits helps lower disability after stroke and avoids complications.
Medication
Different treatments and medications identified in the STEPS Stroke instrument have been shown to reduce risk of stroke in selected groups of patients in predominantly high-income countries. These are explained in the following table. Type of medication New and old antihypertensive drugs Aspirin (and Dipyridamole) Anti-coagulant therapy Plavix Intravenous treatment with tissue plasminogen activator (tPA) Used to Lower blood pressure and reduce stroke occurrence. Prevent a new ischemic stroke. Prevent cardiac embolism in patients with atrial fibrillation. Prevent new ischemic stroke Dissolves the blood clots in patients with acute ischemic stroke.
Overview of STEPS Stroke
Introduction
The WHO STEPwise approach to stroke surveillance provides a flexible system and an opportunity for all countries to get started and contribute and share data on stroke.
Basis of STEPS Stroke
STEPS Stroke identifies three different groups of stroke patients who make up the burden of stroke in any given community or population. They are listed in the order of complexity of identifying them: Information on stroke patients admitted to heath facilities (Step 1); Identification of fatal stroke events in the same community (Step 2); Estimates of non-fatal stroke events in the same community (Step 3). Within each Step (1, 2 and 3) there are a further two possible levels of information that can be collected (Core, and Expanded). By using the same standardized approach, all countries can monitor trends within countries and between countries. The STEPS Stroke instrument was developed, in part, by using the protocol from the WHO MONICA Project.
STEPS Stroke diagram
The following diagram illustrates the general concept of the WHO STEPwise approach
To all new stroke events occurring in a well defined population
From Case series
Note: An "ideal" stroke incidence study requires that all eligible stroke occurring are identified in residents of the defined source population,
Overview of STEPS Stroke, Continued
STEPS stroke tools
A suite of tools have been developed to help methodically and consistently work through the STEPS surveillance process. This suite of tools is called the STEPS Stroke Starter Kit and includes a: STEPS Stroke manual STEPS Stroke instrument Forms and templates Data entry tool (to create a stroke register).
STEPS stroke instrument
The STEPS stroke instrument is a standardized questionnaire used to collect stroke patient data to be entered into the register using the data entry tool. The STEPS stroke instrument covers three different 'Steps' of stroke case finding (Step 1, Step 2 and Step 3) for a defined population. Within each Step, there are three different levels of data collection of increasing complexity (Core, Expanded, Optional) as follows: Step 1 Hospitalized events (fatal and nonfatal) Fatal events in the community Core Demographic information Time of onset Vital status day 10 Demographic information Death certificates, or Verbal autopsy Demographic information Time of onset Vital status day 10 Expanded Treatment Disability Type of stroke Autopsy/ necropsy reports Type of stroke Treatment Disability Type of stroke Provides data on Stroke admissions and hospital case fatality Stroke deaths
Non-fatal events in the community
Stroke incidence and case fatality
Recommended steps
The optimal stroke surveillance system requires collection of data from all three steps and provision of census data from the source population. Costs and complexity increase with identifying subgroups of patients at each step. The level of complexity will therefore depend on development of health services and resources, and each participating country may collect the amount of data that it finds is feasible. Not all sites will be able to undertake an "ideal" incidence study.
Some Key Definitions And Epidemiological Concepts
Prevalence and Incidence
Prevalence and incidence are fundamentally different ways of measuring the occurrence of a disease although both involve the counting of cases in defined populations at risk. The prevalence of stroke is the number of cases in a defined population at a specified point in time - gives a "snapshot" of survivors at any one time The incidence is the number of new cases of stroke arising in a given period in a defined population - gives an indication of the risk of stroke. Date on both prevalence and incidence become much more useful if converted into rates. A rate is calculated by dividing the number of cases by the corresponding number of people in the defined population at risk.
Calculating the Incidence rate
Incidence rate (I) is calculated as follows: Number of people who get a stroke in a specified time I = ____________________________________________ x (10) 5
Number of people in the population at risk over the length of time during which each person in the population is at risk
Case series
A case series refers to stroke cases identified in specified hospital facilities (numerator) but without reference to a defined population from which they came (denominator). Without a denominator, rates can not be calculated. Even so case series present important clinical information about stroke, perhaps for the first time. Case series are often the beginning of the process which helps establish more robust measures subsequently.
Surveillance: ongoing
While a stroke study can be a one off exercise, surveillance involves commitment to developing the stroke register on an ongoing and /or repeated basis. This may also be in the form of repeat studies (every 5 to 10 years), particularly to look at hospital or population trends. It is recommended that when a STEPS Stroke Surveillance register is launched for the first time, there should be a plan for future follow-up to measure trends. This can be achieved by either of the following methods: continuous surveillance as part of a broader health information system, or annual registers repeated at 5 to 10 yearly intervals. It is recommended that the minimum period of observation is one complete calendar year because of possible seasonal variations.
Setting Objectives
Long term monitoring of stroke
Establishing a surveillance system for long term monitoring of stroke can help to: Understand the clinical profile of stroke patients Develop complete, population-based systems of case ascertainment for stroke Verify the accuracy of routine data systems for monitoring stroke Develop local expertise in epidemiological research methods through education and training.
Size and impact of the problem
Undertaking stroke surveillance also helps to determine the size of the problem and help to determine the following: Incidence, case fatality and outcome of stroke Impact on health care systems of stroke Use of acute hospital beds, rehabilitation facilities, and requirements for community care including impact on families of stroke Use of effective interventions in the acute phase (stroke unit, use of drugs etc).
Stroke Surveillance Process Overview
Introduction
For STEPS Stroke Surveillance to be effective, the whole process needs to be properly planned and organized before being implemented. Guidelines are provided below to help you plan a STEPS stroke surveillance study.
Key stages, tasks and timeframes
The minimum recommended total timeframe to collect data for a STEPS stroke study is 12 months. The chart below shows each of the main stages and tasks in a STEPS Stroke study with indicative timeframes for each phase and task.
ID Task Name 1 Establishment 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

Appoint Site Coordinator Planning and Scoping Identify scope of study Define the surveillance site Identify source population Tailor and translate the Instrument Apply for participation Get ethical approval Set up site office & install DET Trial run Recruitment and Training Recruit staff Train data collection staff Data Collection Hot and cold pursue stroke events Data Entry Enter patient data into DET Data Analysis Conduct data analyses Reporting and Disseminating Results Produce preliminary reports Produce annual report
M1
M3
M5
M7
M9
M11
M13
M15
M17
Section 2: Roles and Responsibilities Overview
Introduction
There are a number of entities involved in coordinating and implementing STEPS Stroke surveillance. Representation is covered at the: country (national or sub national) regional, and global level.
Purpose
The purpose of this section is to provide an overview of the core roles involved in STEPS Stroke surveillance.
STEPS stroke surveillance network
The diagram below shows how the global Stroke surveillance network is organised.
STEPS Stroke Surveillance Site (SSS) Site Coordinator Site Data Collection Team
International Coordinating Committee (ICC) Chair STEPS Surveillance Team Leader (SPP/CHP/NMH) Technical Adviser and Data Analyst
International Advisory Group (IAG) International Stroke Society (1) Chair International Coordinating Committee (1) WHO NCD Regional Advisers (6)
In this section
This section covers the responsibilities for the following roles: Topic Site Coordinator Site Data Collection Staff International Coordinating Committee (ICC) International Advisory Group (IAG) See Page 2-2 2-3 2-4 2-6
Section 2: Roles and Responsibilities V 2.1: Date Last Updated: 9 May 2006
Site Coordinator
Introduction
The STEPS stroke surveillance (SSS) site coordinator is the local principal investigator. This key person is responsible for planning and coordinating the local STEPS Stroke surveillance study. The site coordinator should be familiar with the entire manual to understand the whole STEPS stroke surveillance process.
Skills and attributes
The site coordinator will need to have the following qualifications and, general skills and attributes: Neurological or stroke physician (or study nurse) with proven experience in the field of cerebrovascular disease. Good understanding of epidemiological principles of differences between hospital based stroke registers and population based stroke registers Good understanding of the general philosophy and objectives of the global STEPS Stroke surveillance process. Good written and oral communication skills and proficient in English. Ability to recruit and train interviewer staff.
Level of authority
The site coordinator should have sufficient authority to: Negotiate and obtain resources for the whole stroke study. Oversee progress of the national, sub-national, district or local STEPS stroke surveillance implementation. Contribute to the disease prevention and health promotion activities that will arise from the data gathered by STEPS Stroke.
Core roles
The core roles of the site coordinator may include all or some of the following: Role 1 2 3 4 5 6 7 8 9 Description Planning and preparing for a STEPS Stroke study. Applying for participation. Identifying and securing local funding and / or "in kind" support. Handling ethical approval. Recruiting and training interview staff. Supervising data collection and adjudicating difficult diagnoses. Reporting results. Planning and preparing for future studies. Liaising with the International coordinating unit (ICU), local authorities, WHO NCD regional, country and WHO representatives and other stakeholders. Completing test stroke cases provided by ICU for quality control purposes.
10
Site Data Collection Staff
Introduction
The STEPS Stroke surveillance (SSS) site data collection staff are all those who have been trained to collect the study data and enter it into the stroke register.
Interviewer roles
Data collection roles will depend on the scope of the study. Core roles for a data collection staff member may include all or some of the following. Specific tasks are identified in section 5. Role 1 2 3 4 5 6 Description Actively identifying stroke patients admitted to (or occurring within) the hospital on a daily or weekly basis. Retrospectively reviewing records of stroke patients. Resolving difficult cases (where a patient needs to be assessed by an experienced medical practitioner or neurologist). Recording patient details on the Stroke instrument Entering instrument data into the register (using the data entry tool) Following up with patients at day 28. Liaising with and reporting any difficulties to the site coordinator.
Skills and attributes
Interviewers should have the following general skills and attributes: Good basic knowledge of different clinical symptoms of stroke. Good understanding of the different case finding methods (hot and cold pursuit). Excellent understanding of the stroke definition and the instrument questions. Have a sensitive approach towards people who are in a stressed situation or are recalling a sad moment in life. Good oral, written and keyboard skills. Good attention to detail. Ability to follow instructions consistently but raise concerns when appropriate. Work well with others to achieve results.
International Coordinating Committee
Introduction
The International Coordinating Committee (ICC) provides technical support and guidance for STEPS stroke surveillance.
Objectives
The main objective of the ICC is to oversee the practical and logistic issues relating to the overall coordination and implementation of STEPS Stroke surveillance.
Core roles
The core roles of the ICC are to: register surveillance site participation support the site coordinator provide access and support to STEPS surveillance tools and reference material draft and distribute a regular stroke newsletter oversee the overall implementation of the STEPwise approach to stroke surveillance (STEPS Stroke) analyse hospital registers and help report and share results. ensure quality control. Provide feedback on all drafts of reports before they are submitted.
ICC members
Members of the ICC include: Chair STEPS Surveillance team leader Technical adviser Data analyst
Chair
The ICC chair is responsible for advocacy around STEPS Stroke and overseeing the practical and logistic issues relating to the overall implementation of STEPS Stroke. The core roles include: Advocate on behalf of ISS and WHO at major international stroke meetings. Develop closer links between the major NGOs and WHO around stroke surveillance. Help expand the number of Stroke surveillance sites. Liaise with site coordinators on a regular basis. Report to WHO, ISS and the IAG on a regular basis.
International Coordinating Committee, Continued
STEPS Surveillance team leader
The STEPS team leader, based in the Department of Chronic Disease and Health Promotion, is responsible for the ensuring linkages with the STEPS risk factor surveillance activities. Other activities include: Support and maintain the linkages on the STEPS web page. Receive all applications for participation and refer to the ICU technical adviser. Provide administrative support where required. Arrange meetings of the International Advisory Group during routine WHO retreats of the NCD Regional Advisers. Update the mapping of STEPS stroke sites in line with the STEPS risk factor surveys.
Technical adviser
The technical adviser is responsible for: Supporting participating stroke surveillance sites (SSS) with general information about the manual. Providing technical support to participating SSS. Keeping a log of all registered surveillance sites. Preparing first drafts of the annual report and collating comments from site coordinators. Providing information/data as requested from the ICC chair, ISS, and WHO. Ensuring relevant WHO regional and country people are informed. Updating and maintaining the Stroke STEPS Stroke surveillance manual.
Data analyst
The data analyst is responsible for: Developing and maintaining Stroke data entry tool (DET) in collaboration with the technical adviser. Modifying the Stroke DET in accordance with experience from the feasibility study of the SSS. Collecting and collating data for the annual report. Supporting data analyses, data reporting of core indicators and participating in data interpretation. Contributing to the annual report and annual update of the stroke manual.
International Advisory Group
Introduction
The international advisory group (IAG) provides global stroke surveillance coordination.
Members
Members of the IAG include: President, International Stroke Society ICC chair WHO STEPS Surveillance team leader WHO NCD regional advisers (6)
Core roles
The core roles of the IAG are to: Act as an advocacy body for stroke surveillance. Assist in translating the data into policy and programmes. Ensure the long term sustainability of STEPS Stroke surveillance. Oversee overall strategic direction and annual work plans. Provide feedback on quarterly progress reports. Identify potential participating stroke surveillance sites. Assist with fundraising efforts.
Section 3: Planning and Preparing a Stroke Study Overview

Introduction
This section covers the tasks that need to be conducted to plan and prepare for a STEPS stroke surveillance study. This section is primarily designed to be used by those fulfilling the role of the Site coordinator and associated advisory group.
Intended audience
Using existing case registration systems
In some settings, there will be other hospital-based chronic disease case registration systems that cover large populations. Where these systems already exist, consider working with the registration teams and adding stroke surveillance to their work.
In this section
This section covers the following topics: Topic Process Overview and Eligibility Identifying the Scope Defining the STEPS Stroke Surveillance Site Identifying the Study Population Modifying the Stroke Instrument Applying for Participation Getting Ethical Approval See Page 3-2 3-3 3-5 3-7 3-9 3-11 3-12
Section 3: Planning and Preparing a Stroke Study V 2.1: Date Last Updated: 9 May 2006
Process Overview and Eligibility
Introduction
Before registering an interest in applying for participation in STEPS Stroke (see section 7b), some initial prerequisite actions and criteria must be defined.
Process overview
The table below shows each stage in the planning, scoping and eligibility process. Stage 1 Description Define the type and scope of the study (Step 1, 2, 3). The three options are as follows: - a hospital register case series (Step 1 with no population base) - a hospital register linked to a defined population base (Step1) - an incidence study linked to a defined population base (Steps 1-3) Identify the study site. Identify the defined study population from which the cases will be derived (see Section 1-12) If the source population is Then.. Available Apply for full participation Not available Apply for limited participation (case series only) 4 5 6 7 Prepare the instrument. Obtain sustainable funding. Apply for participation. Get ethical approval.
2 3
Note: Each of these stages is explained in more detail below.
Identifying the Scope
Introduction
The focus of STEPS Stroke surveillance is reflected in the core of the stroke instrument. All countries should be able to undertake the core items of Step 1, although not all countries will have access to the defined population from which the stroke events arise.
Stroke study design
The table below provides an overview of the different designs of a STEPS Stroke study. The usefulness of the study is influenced by the quality, completeness and population coverage. A case series poses the greatest challenge in interpretation, but may be the only option in those countries where there are no census data for the catchment area covered by the selected hospitals. (see Section p1-12, 1-13). Step 3 Defined Study Population available No Defined Population Available Step 2 Step 1 Step 1 Case series Incidence rates (hospital + fatal& non fatal strokes in the community) Case fatality (hospital events + fatal strokes in the community) Hospital rates
Step 1 data collection
Step 1 focuses on residents (preferably of a defined study population) who are admitted to a health facility (hospital) with a stroke which meets the WHO definition. A hospital based stroke register provides data on: Step 1 Core Register of Stroke admissions Severity of stroke Survival rates for this group of patients Pre-stroke exposure to major risk factors
Expanded
Step 1: Main outcomes
The main outcomes from this Step include: Health facility resources allocated to stroke patients Functional status of stroke patients at discharge. Risk factor exposure. Hospital admission rates when combined with population estimates from which the stroke patients are derived. Note: Step 1 alone does not provide estimates of stroke incidence in the population because some patients die before hospital admission can be arranged and others are cared for in the community rather than in hospital.
Identifying the Scope, Continued
Step 2: Data collection
Step 2 builds on the hospital register in Step 1 by validating death certificates from routine sources to include fatal stroke events that have occurred in the same community but out of hospital. These data are derived from death certificates need to be validated by verbal autopsy (see section 5-5, 5-6).
Step 2: outcomes
The main outcome from Step 2 (combined with the data from the hospital register from Step 1) is calculation of specific mortality rates and years of life lost due to stroke in the study population. These can be broken down by: Age and sex Proportion of fatal events occurring outside of health facilities Years of life lost because of stroke (YLLs).
Step 3: Data collection
The surveillance of stroke is complicated by the fact that a high number of cases are not admitted to hospital. Step 3 is therefore the most challenging subset of eligible patients to identify. Their identification is vital for the accurate determination of stroke incidence. These strokes are a combination of milder and more severe strokes than those that come to hospital, and consequently their inclusion influences case fatality.
Step 3: outcomes
The main outcome from Step 3 (combined with Step 1 and Step 2 results), is the calculation of incidence and case-fatality. It also allows estimates of: Stroke incidence, prevalence, and case fatality Years of Life lived with Disability (YLDs) Estimate of needs for long term care.
Recommended scope
The minimum recommended scope for most countries should be Step 1 preferably with a well defined source population from which eligible patients are derived. Some countries will be able to achieve a population based register (involving all 3 steps). This provides the most valuable epidemiological measures for public health initiatives for stroke prevention. It is therefore recommended that there is an intention to advance the study to include all three Steps or subgroups of patients, if resources allow and access to central death certificates is available.
Financial support
Once you have identified the scope of your study, you will need to set out a budget and seek financial support (from local or national sources or in kind) to cover all expenses of the study for the whole study period.
Defining the STEPS Stroke Surveillance Site
Introduction
The next stage in the process of being eligible to participate includes identifying and/ or describing the STEPS stroke surveillance site. This may differ depending on the type of register being planned: case series or one which produces hospital trates.
Step 1: hospital based register
When developing a hospital based register is to be linked to a population, all health facilities, or network of health facilities, that are found within the defined population need to be identified and involved in the study. These could include: All health facilities in the (source population) area A small group of health facilities that admit most stroke events Wards within defined health facilities that admit most stroke events. Note: To define the health facilities, complete the hospital information form in section 7d . Once defined, the (group of) selected health care facilities, together with the source population, will be referred to as the STEPS stroke surveillance site (SSS).
Step 2: strokes dying outside hospital
Key case finding sources include access to routine death certificates and an ability to verify all deaths possibly due to a stroke event (including "old age") by use of verification using verbal autopsy techniques.
Step 3 events cared for only in the community
Key case finding sources for stroke cases cared for entirely at home, involves the collaboration and cooperation of, among others, to ensure ongoing support and referral of eligible cases to the study and may involve the following: General practitioners and other health care providers in the community who need to notify the study team of all such events Community health nurses and village elders/church leaders or Alternative medicine practitioners, faith healers etc
Defining the population
Once you have defined the source population or community (preferably from the most recent census) from which the stroke cases will be identified, send the ICU a copy with the application (see section 7d).
Patient eligibility
A patient is eligible for inclusion in the stroke study, if: A resident in the defined population of the stroke surveillance site, Meets the age selected (see Section page 3-8) Has a stroke event within the defined period of time
Defining the STEPS Stroke Surveillance Site, Continued
Estimation of expected stroke events
To be eligible to participate, a minimum of 250 stroke patients per year in the source population from which the cases will be derived, (i.e. hospital and / or community) is necessary in order to Ensure meaningful analysis of the data by age and sex Have sufficient numbers to detect trends over time. These can be based on previous experience or the results of a pilot study.
Data collection timeframe
As a minimum, stroke event registration should be undertaken continuously over a period of 12 months in the defined surveillance site because it has been shown that stroke occurrence varies at different times of the year (see Section 1-12).
Identifying the Study Population
Introduction
Calculation of epidemiologic rates is based on the number of stroke events occurring in the defined population at risk. The ideal population comes from a well defined geographic area. One of the first steps in setting up surveillance studies is therefore to specify and describe the population in which the study is going to take place. This is particularly important if an incidence study is being planned (all 3 steps used in case finding).
Requirement
A defined source population should include population counts broken down by: Each age group to be included in the stroke surveillance study Sex, and Total counts.
Source of information
In many settings, source population counts can be obtained from: Population census lists Inter census estimates Population registers.
Where source population data does not exist
In settings where data for a well defined geographic population does not exist, you will only be able to produce a case series stroke register. Interpretation of this data over time poses major challenges because of changing hospital practices and because of lack of information about the nature of the population from which the cases come.
Balancing population coverage and number of stroke cases
Sites that wish to estimate admission rates for Step 1 and/or do Step 2 and Step 3 must provide an accurate estimate of the defined study population at the time of application. To provide a reliable estimate of the impact of stroke occurrence, representative regional population coverage (from around 250,000 total population up to 1 million) is recommended. Including more than 1 million people is usually not possible and would require a sample system to be established and a much larger team than the one recommended in this Manual.
Identifying the Study Population, Continued
Factors to consider
The table below lists some factors to consider for population coverage. Coverage Districts Guidelines Consider both urban and rural. Note: Often there are differences between urban and rural districts with respect to exposure to risk factors, treatment of predisposing diseases, for example hypertension, and access to health authorities and facilities. Include both private and public (state run). Include both men and women. Allow a representative range of socio economic groups.
Hospitals Gender Socio economic status
Age range
For practical and financial reasons, you should restrict the Core study to age groups where stroke usually occurs, for example from age 45 to 84 years. If you need to expand the study to assess stroke cases in the very young or very old, you may wish to include other age ranges. See the table below for guidance on expanded and optional age ranges. STEPS levels Core Expanded Age range (years) 45-84 15 - 44 85 +
Note: It is often difficult to determine actual stroke in the very elderly due to comorbidity. Including the expanded age range 85+ can therefore skew results.
Sex
Stroke rates are often higher in men than in women, although the differences are not as marked as for other chronic diseases (such as heart disease). Men and women should be presented separately in all analyses.
Describing the study population
For a stroke surveillance site intending to undertake complete coverage of possible stroke events occurring in residents in the defined population, details are requested as part of the process of applying for participation in STEPS Stroke Surveillance (see section 3-12). This form is available in section 7b.
Modifying the Stroke Instrument
Introduction
The Stroke Instrument is a standard document that allows comparisons and international trends analysis and should not be changed. It uses a standard international calendar and is the basis for the standard data entry tool.
Minor modifications
Despite the need for standardization, some minor local modifications may be required in some settings (for example, to clarify terminology, or provide a more comprehensive assessment of stroke occurrence and treatment). The following table provides guidance on possible situations where the Instrument may be modified to local requirements. Modification type Terminology If.. The terms used in some Core standard questions do not fit the cultural setting (for example, ethnicity). You require additional data on stroke occurrence and treatment (for example, use of tPA) and you have available resources. You require specific data to link to previous surveys Particular expanded (only) questions are not covered in study scope. Then.. Alter the term for local relevance, but ensure the original meaning is retained. Add selective, but limited questions as Optional items.
Additional information
Link to previous data Expanded questions
Add selective, but limited questions as Optional items Omit these questions
Note: Expansion beyond the basic Core and Expanded questions is suggested only in settings where resources are available and local needs require expansion.
Modification rules
There are some fundamental rules that must be observed when making any modifications to the standard Stroke Instrument. These include: Never delete a question or measure from the Core (unshaded) Instrument. Never change the standard coding numbers. Place additional questions or measures at the end of the relevant section as an Optional item. Do not place additional questions or measures in between other Core or Expanded (shaded) questions. Code added questions or measures coded with the letter 'X' so they stand out Finally, remove from the Instrument any Expanded sections and Steps (i.e. 2 and or 3) that are not being covered by your site. Send your final draft to the ICC for review before starting the study.
Modifying the Stroke Instrument, Continued
Translating the Instrument
Follow the guidelines below to select appropriate translators and ensure accurate and appropriate translation of the Stroke Instrument and all other interviewing materials. Initial translation of material should be conducted by at least one translator (ideally by health and survey experts who have a basic understanding of the key concepts). The Instrument must then be back-translated into the original language by another translator to ensure accurate reproduction of meanings (ideally by linguistic experts who can explain the terms used and suggest alternatives).
Quality standards for translation
The following are recommended guidelines for translation: Translate medical terms into expressions understood by all health professionals. Translate the original intent of the questions with the most appropriate equivalent term in the local language. Develop an inventory of local expressions used as well as comparisons of expressions in other languages. Where there are many dialects and/or languages that are not available in written format, carefully plan specific translation protocols.
Applying for Participation
Introduction
Once you have addressed the prerequisite actions and identified the scope of your stroke study, you will need to register an interest by applying to the ICC for participation in a WHO STEPS Stroke surveillance study ([email protected])
Purpose
The purpose of the application for full participation is to set out: Location and health care facilities to be included in the study Details about the site coordinator (including expertise) Scope of the study and desired goals Details of planned overlapping case finding methods which will be used Defined study population Required resources Financial support Data management environment. Contact details.
Application for participation template
A stroke Application for Participation form can be found in section 7. Once completed, you will need to forward this to: STEPS Stroke Surveillance Surveillance and Primary Prevention (SPP) Department of Chronic Diseases and Health Promotion World Health Organization 20 Avenue Appia CH 1211 Geneva, Switzerland Fax: +41 22 791 47 67 Email: [email protected]
Participation acceptance
Once your application has been accepted by the ICC, you will be given provisional SSS participation status. Full participation will be granted once you have received ethical approval from your local ethical review committee. You will receive the following from ICC: Acceptance stage Provisional Received from ICC Stroke surveillance site code Interviewer codes Hard copy of the Stroke Manual Password to logon to the STEPS stroke web site and download the data entry tool
Full
Getting Ethical Approval
Introduction
To ensure that each stroke survey is conducted in a technically and ethically sound manner and in appropriate consideration of the local context, every stroke surveillance application should undergo ethical review and approval.
Process
Ideally, ethical approval should be sought by submission of a proposal and application to a hospital ethics review committee or other relevant body. Where no such established process exists, it is recommended that an application for ethical review be prepared and submitted through an ad hoc local mechanism within the Ministry of Health.
Making a submission
Follow the steps below to make a submission and obtain ethical approval and access to information used as the sampling frame for the survey. Step 1 2 Action Draft a formal submission. Identify and contact the relevant committee, seeking guidance on rules, submission processes and procedures and committee sitting times. Adapt submission as necessary and submit to the appropriate committee requesting guidance on expected timeframe for approval. Note: Emphasize that all data collected are kept confidential. Follow-up with committee to get clearance.
Note: The STEPS stroke coordinating committee can provide further advice on making a submission.
Expected timeframes
Preparing and obtaining approval for submissions to ethics committees can take weeks and even months depending on their rules of operation and how often committees sit.
Possible issues
Some of the issues that can occur while trying to gain ethical approval include: Committee does not sit for months Committee takes too long to provide consent Ethical approval is declined The committee wants modifications to the instrument that threaten its value.
Getting Ethical Approval, Continued
Informed consent
In addition to getting ethical approval for the study, it is also recommended that there is a process for patients to give verbal and/ or written consent before taking part in the study.
Approaching participants
Important issues to raise in obtaining consent for potential participants or their family members include the following: Introducing the institution carrying out the study Stressing confidentiality Indicating voluntary nature Reaching agreement on consent to participate.
Consent letter
A model of a consent letter for patients to give verbal and/ or written consent before taking part in the study is given below. See also section 5, data collection guidelines.
STEPS Stroke Patient Consent

Dear patient
Introduction
This study is being conducted by the World Health Organization in collaboration with the Ministry of Health, the International Stroke Society and the WHO Regional Office. It is being carried out by professionals from (name of institution). The study is currently taking place in several countries around the world.
Confidentiality
The information you provide is totally confidential and will not be disclosed to anyone. It will only be used for research purposes. Your name, address, and other personal information will be removed from all records and only a code will be used to connect your response to the study. You may be contacted by the study team again to complete information for the study.
Voluntary participation
Your participation is voluntary. If you have any questions about this study you may ask me or contact (name of institution and contact details) or (the site coordinator).
Consent to participate
Signing this consent indicates that you understand what will be expected of you and are willing to participate in this study. Read by Participant Agreed Interviewer Refused
Signatures
I hereby provide INFORMED CONSENT to take part in the STEPS Stroke surveillance study.
Name: Next of kin: Witness:
Sign: Sign: Sign:
Section 4: Preparing the Stroke Surveillance Site Overview
Introduction
Once your application for participation has been accepted, and you have received your Stroke surveillance site code (SSS code), you will be able to recruit or obtain staff through secondment and set up the data entry tool.
Intended audience
This section is designed for use by those fulfilling the role of the site coordinator.
In this section
This section covers the following topics: Topic Recruiting Staff Briefing and Training for Data Collection Staff Setting up the Stroke Surveillance Site Installing and Preparing the Data Entry Tool Test Run See Page 4-2 4-3 4-4 4-5 4-7
Section 4: Preparing the Stroke Surveillance Site V 2.1: Date Last Updated: 9 May 2006
Recruiting Staff
Introduction
The number and type of staff recruited to do data collection will depend on the following: Scope and size of the stroke study (including Step 1, 2 and or 3) Source of data to be collected (ie active recruitment, or retrospective record review) Qualifications and skills of interested applicants.
Core roles
The core roles of data collection staff are covered in section 2.
Where to get people from
In many countries, recruitment is likely to be an informal process where staff are 'seconded' from other duties within a health facility or health authority. For example, junior staff in training. In this situation, arrangements for their release or scheduled participation may need to be negotiated and explicitly agreed upon. Where there is not sufficient available staff or specific skills are required formal recruitment may be necessary.
Number of staff
For a STEPS Stroke study that intends to register prospectively 250 cases per year, you will need to recruit two data collection staff. It is normal to screen a much larger number of patients with a range of strokelike symptoms even vaguely suggestive of a stroke. Data collection must be ensured during sick leave, annual leave, etc. More staff may be needed if data collection is spread over a large area. This includes multiple hospital coverage and in places where death certificates are not centralized.
Briefing and Training for Data Collection Staff
Introduction
Training is likely to be informal and will depend on the level of skill and qualifications of data collection staff.
Purpose
The purpose of the briefing and training is to ensure: Uniform application of the steps stroke surveillance materials Good overall quality of data collected, and Useful and meaningful results reported.
What to cover
Depending on the qualifications and skills of staff recruited and type of data collection, briefing and/ or training could cover some or all of the following topics: Topic STEPS stroke surveillance What to cover Basis of STEPS stroke and rationale for the study About stroke Key definitions and epidemiological concepts Key vascular risk factors Medical treatment Roles and responsibilities of data collection staff Methods for identifying stroke patients (hot and cold pursuit) Interview skills Recording patient responses Using the STEPS stroke instrument Using the Q by Q Guide Administration Test cases Using the data entry tool Reference Section 1
Roles Data collection
Section 2 Section 5 Section 7
Updating the stroke register
Section 6
Setting up the Stroke Surveillance Site
Introduction
To set up the STEPS stroke surveillance site, an office space will need to be identified or established for: Coordinating the steps stroke study Entering patient data entry into the data entry tool, and Maintaining the stroke register and relevant files.
Office equipment and supplies
General office equipment and supplies required for the stroke surveillance site office include: Photocopier Shelving Filing cabinets or boxes Telephone At least one computer with internet connection Office stationery supplies
Software
The following is a list of software that you will need to have setup on your office computers: Microsoft Office '98 or higher recommended for reports, correspondence and general word processing. Virus scanning software (if connected to the internet and/ exchanging files outside the office). MS Access ('98 or higher) for data entry. Standard Data Entry Tool (DET). For information on installing the DET see page 4-5 and for further information on using the DET see section 6. Note: The DET is a standard tool that is only available in English.
Other technical requirements
To conduct an "ideal" stroke incidence study, you will need access to brain imaging equipment at the surveillance site. This may not be feasible in all settings.
Installing and Preparing the Data Entry Tool
Introduction
It is important to properly set up and install the Data Entry Tool (DET) prior to starting data collection. The setup process involves: creating a folder for the DET receiving and installing the DET preparing the DET for data entry.
Create DET folders
Follow the steps below to create appropriate STEPS Stroke folders on the computer that will be used to enter data and establish a register. Step 1 Action In Windows Explorer, create a primary folder (directory) for all your Stroke files, including: data code documents, and other files. Create a sub-folder under the STEPS Stroke primary folder to contain your data files Recommended folder name Use either: C:\SSS200X(insert appropriate year), or other appropriate drives if your disk is partitioned you are on a network. C:\SSS200X\data
Receiving the DET
Once you have been authorized by the ICU to participate in a STEPS Stroke study, the ICC data analyst will email you the appropriate version of the DET. Note: Make sure you have ordered the version of the DET which corresponds to the Microsoft Access version on your computer or local network (e.g. DET for MS Access 97).
Installing the DET
Follow the steps below to install the DET onto your computer.
Step 1 2
Action Unzip the DET attachment In Windows Explorer, copy the following files into the C:\SSS200X folder: WHO_Original.mdb WHO_Original_Data.mdb Note: All export files of the Data Entry Tool are automatically stored into this folder.
Installing and Preparing the Data Entry Tool, Continued
Installing the DET (continued)
Step 3 4 5 6 7 8 9
Action In Windows Explorer double click the file: WHO_Original.mdb Click OK in the Entering SSS code box. Click on the SSS code button in the configuration window. Enter your SSS code and click OK in the SSS code window. Repeat step 9 to confirm your SSS code. Click the Close button in the configuration window. Click the Close button in the start window.
Error messages
You will get one of the following error messages if you incorrectly entered your SSS code and will need to repeat steps 7-10 above to correct: invalid data entry wrong sss code invalid SSS code.
Test Run
Introduction
Prior to starting the stroke study, it may be useful to complete a test run of the: STEPS stroke instrument case finding process access to records case registration process, and data transfer of results.
Test patients
Identify and approach a sample of 25 patients to be part of the test run. If possible, the test cases should include: both men and women people with differing levels of education a broad age range (within the target study range) more than one ethnic group (if appropriate).
Feedback
At the end of each interview, ask the patient the following questions and record their feedback: Did any of the questions make you feel uncomfortable? How could we improve the format or layout? Were there activities that we missed? How else could we improve this survey?
Evaluation and refining the Instrument
On completion of the trial: Compile all patients' comments into a single report. Where necessary, adapt and refine the Instrument - taking care not to change intended meanings. Send the instrument to the ICC for comment and quality assurance. Note: The ICU will also provide feedback on the overall quality of collected data.
Section 5: Data Collection Guidelines Overview
Introduction
This section provides generic guidelines for data collection staff.
Intended audience
This section is designed for use by those fulfilling the following roles: Interviewers Stroke principal investigator
In this section
This section covers the following topics: Topic Case Finding Methods Identifying Stroke Patients in Hospitals (Step 1) Identifying Fatal Stroke Patients in the Community (Step 2) Estimating Non-Fatal Stroke Events in the Community (Step 3) Interview Skills Recording Responses for Registration Completing the Stroke Instrument Guide to Completing the Instrument: All Stroke Events Guide to Completing the Instrument: Events Admitted to Hospital (Step 1) Guide to Completing the Instrument: Fatal Community Events (Step 2) Guide to Completing the Instrument: Non-Fatal Community Events (Step 3) See Page 5-2 5-3 5-5 5-7 5-9 5-11 5-12 5-13 5-15 5-21 5-22
Section 5: Data Collection Guidelines V 2.1: Date Last Updated: 9 May 2006
Case Finding Methods
Introduction
The main case finding methods used to identify stroke cases are: Hot pursuit (active, ongoing recruitment) Cold pursuit (retrospective record review) Combination of hot and cold pursuit.
Hot pursuit
Hot pursuit refers to ongoing 'active' identification of all stroke events as they occur. The main purpose is to confirm that the criteria for stroke is met and ensure complete identification of all events including mild stroke events. Hot pursuit involves regularly checking the following: Daily hospital admissions, Hospital separations or discharges Emergency room registers Wards or units Death certificates.
Cold pursuit
Cold pursuit refers to retrospective identification of stroke events, for example, based on information from hospital discharge records, or death certificates. This identification method relies on diagnoses made by several doctors of varying neurological experience who are not working to a protocol. It requires a team identifying and validating stroke events when it is convenient, based on information from routine data sources. Direct examination of the patient is often not possible, and the diagnosis is based on data from records.
Combined approach
Many studies use a combined approach with a mix of hot and cold pursuit to ensure the most complete identification of stroke events (so called overlapping identification sources or overlapping sources of information). Some of the patients must have been identified as soon as possible after symptoms onset with the possibility of direct examination, while the remaining events are based on routine data. For example, the researchers have done direct examinations after hospital admission but to ensure the completeness of the data, hospital discharge records, death certificates etc. are checked, physicians are asked to report non-hospitalized stroke events.
Identifying Stroke Patients in Hospitals (Step 1)
Introduction
Surveillance of stroke managed in hospitals should be limited to patients who: Are admitted to any unit, ward, division or department of the hospital with a provisional diagnosis of having experienced the onset of a new stroke. In-hospital patients who suffer a stroke due to the treatment of another disease.
Identifying stroke patients
Stroke patients may be identified through the following hospital systems and channels: Emergency room daybook (or register) Admissions book (or register) Outpatient clinics Radiology departments Specialist physicians or neurologists Physiotherapists, speech or occupational therapists Discharge records Death certificates Note: It is necessary to devise systems in each hospital to detect patients who suffer from an in-hospital stroke, whether intra-operatively or at some other time, and whether in acute or on long-stay wards.
Difficult cases
While many cases are straightforward, stroke has a long differential diagnosis. Resolving the difficult cases requires that the patient be assessed by an experienced medical practitioner and preferably by an internal physician or a specialist neurologist. Re-assessment of the patient at least 24 hours after the initial presentation may be vital to differentiate stroke from TIA and other neurological or medical diseases such as hemiplegic migraine and epilepsy.
Death following stroke
In order to assess trends in case fatality, a system for accessing details on all deaths occurring in stroke patients registered in the study is necessary. Date of death should be registered in the Instrument, together with details of cause of death. Vital status of all patients should be known at 28 days after the onset of stroke. This length of follow up is not always feasible. A minimum follow up is 7 days.
Identifying Stroke Patients in Hospitals (Step 1) Continued
Diagnostic criteria
Each registered stroke event must meet the standard WHO clinical definition of stroke (see p1-4). Key features of the clinical definition are as follows: Sudden onset Neurological deficit Lasting 24 hours or longer Of presumed vascular origin. The table below provides an example of some of the diagnoses that should be considered for STEPS stroke registration. Stroke specific (Acute) stroke or (acute) cerebrovascular episode Cerebral or cerebellar embolus, thrombosis or infarction Occlusion, thrombosis or embolus of carotid, (pre) cerebral or vertebral artery Lacunar hemorrhage or stroke Subarachnoid, (primary) intracerebral, cerebellar or pontine hemorrhage or stroke Ruptured berry aneurysm Transient (cerebral) ischemic attack Focal and global signs that could be caused by stroke (Acute) hemiplegia or (acute) hemiparesis Faint, fit, funny turn, (acute) confusional state Loss of consciousness (Acute) dysphasia, dysarthria, dyspraxia Homonymous hemianopia Amaurosis fugax Acute monocular blindness
Note: Further details on symptoms for the three major stroke types can be found in section 1, About Stroke.
Residency criteria
If a population based study, the stroke case, to be eligible, must be resident in the defined population at the time of the onset of the stroke.
Identifying Fatal Stroke Patients in the Community (Step 2)
Introduction
The three main methods for identifying and estimating the number of stroke patients that die from a stroke, but who do not reach hospital facilities: Death certificates Verbal autopsies Medical autopsy.
Death certificates
Communities that have routine medical certification of cause of death can provide direct data on deaths due to stroke. Note that delays in processing death registrations and certificates may occur and also a wide variety of terms may be used to describe fatal stroke. When in doubt, verification or follow up is essential. Methods for searching death registrations may include: Electronic keyword search Manual record search by visual sighting.
Verbal autopsies
Verbal autopsies (VAs) are increasingly being used to monitor the distribution of deaths by cause in places where medical certification of cause of death is uncommon. This technique is based on the assumption that most causes of death have distinct symptom complexes, and that these can be recognized, remembered and reported by health professionals or lay respondents. Official WHO verbal autopsy for adult deaths is currently being developed. A provisional form for assisting with the process of verifying deaths which may possibly have been due to stroke is available on request from the ICC for those SSS planning population based registers. Follow up with this modified VA is essential where cause of death is cited in such vague terms as: Ill defined Unknown "old age" Senility. Sensitivity in obtaining this information must be adhered to at all times.
Identifying Fatal Stroke Patients in the Community (Step 2),

Continued
Verbal verification
When interviewing health professionals or family members about the signs and symptoms associated with a possible stroke event, the following questions provide a structure to the interview: Was the deceased ill prior to death? Did s/he have weakness on one side of the body prior to death Did that weakness develop suddenly? Did it last more than 24 hours? Was it a sudden death (died within 24 hours)? Was there a history of severe headache just prior to death? How many days was the patient ill before death? Was the patient seen by a medical or health professional? Was the patient admitted to hospital or a clinic? How many nights? A detailed description of the previous illnesses, treatment, and events leading to death should be prepared and used in the decision by the study coordinator as to whether the criteria for stroke have been met.
Validation of codes and diagnosis
Both the codes used and diagnosis of stroke as the immediate or underlying cause of death should be validated as indicated in the table below. Validation of Codes Based on Medical and medico-legal records (within 28 days of death). Interview with decedents next-of-kin or other informant (verbal autopsy). Clinical signs according to the stroke definition Neuro imaging or autopsies.
Diagnosis
Medical autopsies
Since medical autopsy rates are declining in many countries autopsies are unlikely to provide a substantial coverage of fatal strokes. However, records of post mortem examinations are an accessible way of getting information for the surveillance system. They provide a valid diagnosis, and contribute to a more complete understanding of the stroke occurrence in the study population.
Estimating Non-Fatal Stroke Events in the Community (Step 3)
Introduction
The main methods for estimating numbers of non-fatal events in the community include: Tracking local medical practices and health facilities by survey Hemiplegia/ hemiparesis survey (prevalence survey)
Primary health care facilities
Where general practitioners are widely used at primary health care facilities, these should be included as part of the case finding methods. In some countries there are only a few general practitioners or only a proportion of stroke patients who ever have contact with them. In these sites, local healers may be the primary contact person and it is important to consider their potential for collaboration.
General practitioners
You will need to use different survey techniques depending on the size of the study population to determine the number of general practitioners to include, as indicated in the table below: If the study population is Small (limited size) Then.. Include all the general practitioners and local health facilities in the study (eg. public health care centres, nursing homes, rehabilitation centres etc). Survey a representative sample of medical practitioners to assess the number of cases that they have managed over a defined, preceding period.
Large (entire population)
Local healers
Given instructions on stroke symptoms, local informal healers may be able to provide a contact to the patient, who then can be examined for stroke symptoms. Note: This procedure is likely to underestimate the true rate as mild cases are unlikely to be detected, but the overall effect on the estimates is likely to be minor.
Estimating Non-Fatal Stroke Events in the Community (Step 3), Continued
Sampling community based facilities
Informing the community about the purposes of a stroke surveillance system is crucial in enlisting assistance in case finding for the hard to reach people who are not listed with a registered facility or hospital. Identification of these patients involves the collaboration and cooperation of general practitioners and other health care providers in the community, but their identification is vital for the accurate determination of stroke incidence. These strokes are a combination of milder and more severe strokes than those that present to hospital, and consequently their inclusion influences case fatality ratios. One approach is to notify all general practitioners (or equivalent) of the study. They should be provided with information kits and memory aids to focus their attention on the study and to alert the team to any cases in their practice who have a stroke- especially if not admitted to a hospital. In addition to general practitioners (or equivalent), the study team will need to maintain close liaison with community health nurses and village elders/church leaders to ensure ongoing support and referral of potentially eligible cases to the study.
Prevalence of stroke Hemiplegia/ hemiparesis survey
One way of estimating the proportion of non fatal stroke events is to obtain an estimate from the prevalence of survivors. In most communities the causes of adult-onset hemiplegia or hemiparesis are limited to stroke and head injury and can be distinguished from patient history. If the incidence of residual hemiplegia following stroke and the survival time are constant within a given community, trends in the prevalence of hemiplegia will reflect trends in the incidence of stroke. This could be useful for stroke surveillance because hemiplegia is recognisable and identifying cases does not require self diagnosis. The prevalence of hemiplegia can therefore be identified by questionnaire based population surveys or interviews with a representative from selected households. The problem, however, is that even prevalence of stroke is relatively rare. If such a survey has already been undertaken, check to see if information was obtained on the proportion who said they had never been admitted to a hospital facility. This could act as a proxy measure of the non fatal community based group. Notes: The linkage between prevalence of hemiplegia/ hemiparesis and incidence of stroke has not been validated in a study so far.
Interview Skills
Introduction
Although much of the data that needs to be collected can be obtained from records, some contact with patients or next of kin may be required.
Participation
The patient (or person being interviewed) needs to feel comfortable about the interview and can refuse to be interviewed as participation is voluntary. The interview should therefore be as natural as possible and conducted politely, like a normal conversation.
Behaviour and tact
The table below provides guidelines on appropriate behaviour during an interview: Behaviour Guidelines Respect confidentiality Maintain the confidentiality of all information you collect. Respect patient's time You are asking patients for their time so be polite and prepared to explain. Tact If you feel that a person is not ready to assist you, do not force them but offer to come back later. Friendly disposition Act as though you expect to receive friendly cooperation and behave accordingly. Body language Maintain good eye contact and adopt appropriate body language. Pace of interview Don't rush the interview. Allow the patient enough time to understand and answer a question. If pressured, a patient may answer with anything that crosses their mind. Patience Be patient and polite at all times during the interview and ensure you have set aside enough time for patients with aphasic disturbances. Appreciation Thank them for their help and cooperation.
Interview Skills, Continued
Handling refusals
Be prepared to obtain co-operation from a patient who does not want to be interviewed. In general, be pleasant, good-natured, and professional and most patients will co-operate. If The patient becomes defensive Then Show patience and understanding Provide token agreement and understanding of his/her viewpoint, that is, saying something like, I can understand that or You certainly have the right to feel that way. Convey the importance of the study to the patient and that all stroke patients are being registered. Try again later. Try to explain the purpose again.
You may have visited at a bad time. The patient may have misunderstood the purpose of the visit. You think you may get a 'no'
Try to leave and suggest coming back later before you get a partial or an absolute no.
Patient consent
Each patient (or family member) should provide verbal and/or written consent in accordance with local standards before taking part in the Study. A sample patient consent form is discussed in section 3-14.
Recording Responses for Registration
Introduction
All results that are recorded on the STEPS instrument must be written as clearly as possible to avoid ambiguity and confusion when checking and entering the results.
Requirements
Some general requirements for recording survey information are as follows: Record the patient identification number on every page of each instrument. Do not erase any notes made. If a question has been skipped by mistake, correct it. If a patient changes his/her mind on one of the options, record the new answer. Record only answers that are relevant to the study. Record comments or explanations in brackets in the Instrument next to the corresponding question. Do not get too absorbed recording. Keep the patient's interest by saying the patient's response aloud as you write it down. Standard agreement on how to write numbers.
Handling issues
Use the table below to help with some common issues you may encounter. If.. You are uncertain about a response A question doesn't apply or the patient doesn't know and these options are not available on the Instrument You have missed a question Then.. Repeat the question and record the answer exactly. Do not paraphrase a response. For "dont know" record: 9, 99 or 999 etc. Go back and ask the question, making a note that the question was asked out of sequence.
Checking and editing
At the end of each interview check the Instrument and make sure that: All the questions have been answered. The information recorded is clear and legible for others to read. Probing comments are indicated. Check that all the information has been completed including the ID number on every page. Review the Instrument to check it is complete and that every question has been answered.
Completing the Stroke Instrument
Introduction
Once the standard stroke Instrument has been translated and printed it is ready for use during the study. One Instrument is to be completed for every eligible stroke event. Note: one person may have more than one stroke event over the year of observation. All items on the Instrument must be completed for the response to be valid.
Cover page
The bottom part of the first page of the Instrument contains identification information, including the patient names. It is very important that these details are kept confidential at all times and that you tell the patient that they will be kept confidential.
Core and core expanded items
The Instrument contains Core (un-shaded) and Expanded (shaded) response options for each Step you will need to complete.
Introductory statements
Where a section of items has an introductory statement, you must read this out to the patient.
Entering the patient's response
For some items on the Instrument, there may be one or more possible responses. Each possible response has an associated code. You will need to enter the appropriate response code in the box for each item. For example:
Stroke classification (S1 6) What subtype of stroke was diagnosed? [select one] Ischemic stroke Intracerebral hemorrhage Subarachnoid hemorrhage Unspecified type (1) (2) (3) (4) [2]
Unknown responses
The table below shows what to enter as a last resort where the patient does not respond with a standard response. If a hospital record or patient response is Unknown Don't know Unknown Dont know Unknown Dont know And number of [ ] is [ ] [ ][ ] [ ][ ][ ] Then enter 9 99 999

Section 5: Data Collection Guidelines V 2.1: Date Last Updated: 9 May 2006 5-12 STEPS Stroke Surveillance
Guide to Completing the Instrument: All Stroke Events
Introduction
Guidelines on how to complete some questions in the All Stroke Events section of the Instrument are given below, with further guidance given in the Question by Question Guide in section 7.
Identification number
The patient identification number is to be written in the boxes at the top of each page of the Instrument and all patient specific documents at the time the completed Instrument is being entered into the register.
Patient identification and patient characteristics I 1 - I 3 (Core)
Accurate core participation and patient characteristic information is essential for analysing and reporting on the overall results of the STEPS Stroke surveillance. Patient identification and patient characteristics should be completed for every patient documented in Step 1, Step 2 and Step 3. If the age and sex of a patient has been missed out, the Instrument cannot be used in the analysis, as most analyses are grouped by these criteria.
Contact name and address I 9 - I 13
An acute stroke event often results in dramatic consequences for the patient after discharge from hospital. This may mean the patient goes to live with relatives or a nursing home for long term care. The contact person, phone number and address should therefore be for someone who knows about the actual living situation of the patient. Children or other close relatives could serve as contact persons for the patient. The relationship of the contact person to the patient should also be documented.
Dates of birth and age I 14 (Core)
In some countries exact dates of birth and/or age are not known. In these situations age has to be estimated. To estimate someone's age, you will need to ask them how old, or at what stage in life they were at the time that a number of widely known major local events occurred.
Information on acute stroke event I 20 - I 22 (Core)
If the exact onset of stroke symptoms is unknown (e.g. stroke occurred during sleeping), ask the patient or another person when the first symptoms of stroke were noticed and enter that date. To differentiate between a first-time event and a recurrent event it is important to obtain information about possible previous strokes. Please note that that the following are not counted as a stroke: previous TIA silent strokes (ie detected by scanning but did not result in a neurological deficit longer than 24 hours).
Completing the Stroke Instrument Continued
Expanded items
Expanded questions are shown in the shaded boxes. Some of these questions may have been adapted so the terms and phrases make sense to patients in your environment. Some of the adaptations may include relevant: Ethnic, racial and or cultural groups Highest level of education Categories of work Income level.
Choosing expanded items
Each site coordinator should choose which of the expanded items will be included in the final Instrument. It is a question of balance between obtaining the minimum data (core items) and what can reasonably added without additional effort and cost. Choosing expanded questions depends on local circumstances and the use to which the information will be put. As with core questions, expanded questions should not be altered.
Guide to Completing the Instrument: Events Admitted to Hospital (Step 1)
Introduction
This section is to be completed for all eligible stroke patients admitted to hospital. Information collected includes: Hospital admission Stroke classification Vascular risk factors Medical treatment Secondary prevention In-hospital management Follow up of the patients Note: Each of these is explained in more detail below.
Hospital admission S1 1 (Core)
Stroke patients admitted to hospital must have survived until hospitalization, and must have been able to get to the hospital either: by themselves with the help from relatives/care givers, or using any kind of emergency medical service. Note: Despite differences between countries and changes in admission practices over time, data based on hospitalized events gives valuable information for local health authorities, and constitutes the first step to a better understanding of stroke in the population.
Hospital departments S1 2(Expanded)
There are seven possible answers for indicating in which departments or units the patient was treated. The available options are explained in the table below. Department/unit Intensive care Medical Neurological Neurosurgical Rehabilitation Stroke Other Refers to patients managed at.. An intensive care unit, including any type of acute medical unit. A general medical ward, including a geriatric unit. A general neurological ward. A general neurosurgical ward. A specialized rehabilitation unit, except a rehabilitation stroke unit. Acute and rehabilitation stroke units. Other units, e.g. outliers or patients on surgical wards.
Guide to Completing the Instrument: Events Admitted to Hospital (Step 1), Continued
Living situation S1 3 (Core)
Living condition options are explained in the table below. Option Independent at home Dependent at home Community facility Refers to patients living Without depending on any assistance from relatives or professionals Depending on assistance from relatives or professionals In nursing or residential homes, serviced flat or other long term care facility.
Modified Rankin scale S1 4 (Expanded)
If possible, the Modified Rankin scale prior to acute stroke event should be assessed retrospectively based on the information provided by patient and/ or close relatives. The number corresponding to the patients functional level is to be entered. The scale is divided into 6 levels (from level 0 to level 5) as described in the table below. Scale No symptoms No significant disability Slight disability Moderate disability Able to walk without assistance Moderate disability Unable to walk without assistance Severe disability Description No symptoms at all No significant disability despite symptoms, ie. can do all usual activities Unable to do all previous activities, but able to look after own affairs without assistance Requiring some help but able to walk without assistance Unable to walk without assistance, and unable to attend to won bodily needs without assistance Bedridden, incontinent, and requiring constant nursing care and attention.
0 1 2 3
Note: The modified Rankin Scale measures independence rather than performance of specific tasks. Mental as well as physical adaptations to the neurological deficits are incorporated, and the score gives an impression of whether the patients can look after themselves in daily life.
Neurological signs S 1 5 (Core)
Neurological deficits, for example, disturbances of consciousness, are an important predictor of stroke severity. Neurological deficits present at the first medical examination after hospitalization should be documented to adjust potential differences in outcome and disability for stroke severity. The different levels of deficit are explained in the table below. Neurological deficit type Disturbed consciousness Refers to Disturbances of consciousness, including semi consciousness, e.g. not fully aroused, and coma, either response to pain only or no response at all Motor deficits of the upper or lower limbs. Speech disturbances present on admission, like aphasia or dysarthria.
Weakness/paresis Speech disturbances
Stroke classification S1 6 (Core)
Stroke events can be classified into either ischemic stroke intracerebral haemorrhage subarachnoid haemorrhage, or unspecified. It is recommended that stroke types are classified as a result of neuroimaging. Whether an event is haemorrhagic versus ischemic is also of importance from a clinical perspective in terms of treatment and early secondary prevention, as aspirin should not be given to patients with haemorrhagic stroke and anticoagulation as well as thrombolysis is obviously contraindicated in hemorrhagic strokes. Where no diagnostic examination was done to verify the subtype of stroke, choose the option Unspecified. Note: For further details on stroke classification, see section 1, About Stroke.
Subtype diagnosis S1 7 (Core)
Diagnosis of stroke subtype, refers to patients where the subtype classification was verified from one of two methods as follows: Diagnosis by Clinical diagnosis alone Explanation Clinical diagnosis alone and was not verified by brain imaging (or in subarachnoid hemorrhage on lumbar puncture) in non-fatal cases or also by medical autopsy in fatal cases; please indicate also clinical diagnosis alone if any scoring system not based on brain imaging or medical autopsy was used Diagnostic techniques In non-fatal cases to patients where the subtype of stroke was verified by brain imaging; subtype verification of subarachnoidal hemorrhage might also be based on lumbar puncture alone; in fatal cases verification of stroke subtype might also be based on medical autopsy.
Risk factors S1 10 (Expanded)
The main modifiable risk factors that are present pre-stroke are listed and defined in the table below. Risk factor Atrial fibrillation Current tobacco use Defined as a patient who pre-stroke.. Has atrial fibrillation in ECG prior to stroke (records seen) or during hospitalization. Is a current tobacco user (smoking and other forms of tobacco), or Was a recent tobacco user but stopped less than 3 months before acute stroke event. Has been diagnosed with or has self reported diabetes mellitus, and Uses antidiabetic drugs Has reported elevated plasma total or LDL cholesterol level, or Uses lipid-lowering medication Has diagnosed or self reported raised blood pressure, or Uses antihypertensive drugs.
Diabetes mellitus
Hypercholesterolemia
Raised blood pressure
Pharmaceutical treatment S1 11 S1 12 (Core)
Pharmaceutical treatment means continuous medication. The only exception is for thrombolysis, which is only given one time. The table below lists the categories of drug type and drugs used in each category. Drug type Anticoagulant Anti diabetic Antiplatelet Including Warfarin Heparin Antidiabetic medications Insulin injections Aspirin Clopidogrel Dipyramidol Statins Thiazides Angio-tensin targeting agents Beta-blockers Calcium channel blockers
Cholesterol lowering Blood pressure lowering
In hospital assessment S1 13 - 14 (Expanded)
The in-hospital assessment questions refer to assessments of the listed disorders during hospitalization, irrespective of whether the patient was treated or not after the first visit.
Patient discharge S1 15 - 18 Core)
If the patient is alive at discharge (S1 18), there are three possible destinations. These are explained in the table below. Option Home Other hospital Refers to patients discharged to Private address (either the same or a new address) Another hospital Rehabilitation unit Rehabilitation hospital Long-stay hospital Facilities with access to service and staff eg: Nursing or residential homes Long term care facilities for psychiatric disorders Serviced flat, or Assisted living
1 2
Community facility
Guide to Completing the Instrument: Events Admitted to Hospital (Step 1) Continued
Modified Rankin scale S1 9 (Expanded)
If the patient is alive at discharge, the Modified Rankin scale should be assessed just before discharge from hospital. The number corresponding to the patients functional level is to be entered. The scale is described on page 5-16.
Follow up at day 28 F1 - F7 (Optional)
Follow up on day 28 (from onset of stroke) provides valuable information about the long-term burden of stroke. These optional questions may be difficult to obtain for all registered patients. If a patient or contact person could not be contacted on day 28, try to get all necessary information as soon as possible, and within the next few days. Some possible ways to follow up with patients after discharge from hospital include: Direct examination, e.g. during a home visit, outpatient department or in hospital. Medical record review, if the patient is still in the hospital at day 28. Telephone interview with the patient or close relative. Questionnaire posted to the patient. Note: Confidentiality, ethical issues and other legal aspects in terms of performing a follow up should be clarified before starting data collection.
Guide to Completing the Instrument: Fatal Community Events (Step 2)
Introduction
Step 2 covers identifying and registering every fatal stroke event treated in community and not admitted to hospital.
How information is collected S2 3 (Core)
There are three main methods for collecting information about fatal stroke events in the community. These include: verbal autopsy death certificates medical autopsy. For further information on each of these methods see page 5-5.
International classification of diseases (ICD) S2 4 - 5 (Core)
The International Classification of Diseases (ICD) system is commonly used to record the cause of death on death certificates. There are three versions of the ICD codes and a range of eight or nine coded diseases that may relate to stroke as the cause of death. Some of these disease will not meet the definition of stroke, but should be included in all broad searches for stroke events. The ICD versions and codes are as follows: Version ICD 8 ICD 9 Codes 430 431 432 433 434 435 436 437 438 I60 I61 I62 I63 I64 I65 I65 I67 I68 I69 Disease Subarachnoid haemorrhage Intracerebral haemorrhage Other and unspecified intracranial haemorrhage Occlusion and stenosis of precerebral arteries Occlusion of cerebral arteries Transient cerebral ischemia Acute but ill-defined cerebrovascular disease Other Ill-defined cerebrovascular disease Late effects of cerebrovascular disease Subarachnoid haemorrhage Intracerebral haemorrhage Other non-traumatic intracranial haemorrhage Cerebral infarction Stroke, not specified as haemorrhage or infarction Occlusion and stenosis of precerebral arteries, not resulting from cerebral infarction Occlusion and stenosis of cerebral arteries, not resulting from cerebral infarction Other cerebrovascular diseases Cerebrovascular disorders in diseases classified elsewhere Sequelae of cerebrovascular disease
ICD 10
Guide to Completing the Instrument: Fatal Community Events (Step 2), Continued
Verbal autopsies (Optional)
The purpose of Verbal autopsies (VA) is to describe cause of mortality at a community or population level where no better alternative resources exist. Verbal Autopsies are based on interviews with friends and relatives of a deceased person. After an interview has been conducted, the following takes place: A panel of physicians reviews the forms and assigns a probable cause of death. Medical records coders trained in ICD rules select and code the underlying cause of death, according to a code score. Mortality results are tabulated using a standard list capable of generating comparable mortality statistics. Unfortunately, the tools and methods employed are often imperfect and require rigorous validation and continuous quality assurance.
Guide to Completing the Instrument: Non-Fatal Community Events (Step 3)
Introduction
Step 3 covers identifying and estimating the non-fatal stroke events treated in community and not admitted to hospital. This is the most difficult component of case finding, and efforts at estimating the number of people who would otherwise be missed by a focus only on patients admitted to hospital are essential to show the true incidence of stroke.
How information is collected S3
There are two main methods for estimating non-fatal stroke events in the community. These include: Tracking medical practices (health facilities) by survey, and Prevalence or Hemiplegia/ hemiparesis survey. For further information on each of these methods see page 5-7. Other methods such as capture/re-capture using multiple overlapping sources are available. Please discuss approaches relevant in your setting with the ICC.
Section 6: Data Entry and Data Management Overview
Introduction
This section covers all the tasks that need to be conducted to enter and manage the STEPS Stroke study data in the Data Entry Tool (DET) to gradually build up a register that can produce study results.
Intended audience
This section is designed for use by those fulfilling the following roles: Data collection staff Principal investigator
In this section
This section covers the following topics: Topic Data Entry Data Management Creating Reports Exporting Data See Page 6-2 6-5 6-7 6-8
Section 6: Data Entry and Data Management V 2.1: Date Last Updated: 9 May 2006
Data Entry
Introduction
STEPS Stroke study data from completed STEPS stroke instruments is to be entered into the data entry tool by trained data collection staff.
Data entry process
Data entry is a systematic process that covers the following main stages: Stage 1 2 3 3 4 Description Entering new patient data. Entering the Identification number on patient instruments. Validation and error correction. Backing up. Storing and filing the instruments.
Opening the DET
Follow the steps below to open the DET start window. Step 1 2 Action Open the DET program by clicking the WHO_Original.mdb file in Windows Explorer. The start window will appear. The function of each button is explained in the table below. Click the button New Patient Search Reports Data Export Delete Patient Close To Enter new patient records Search for entered data Generate reports of entered data Export entered data Delete entered data Close the data entry tool (DET)
Enter all stroke events data
Follow the steps below to enter new patient data from the All Stroke Events section of the completed STEPS stroke instrument. Step 1 2 Action Click the New Patient button in the start window. A unique identification number for each patient will be generated by the Data Entry Tool. Note: This consists of the joint SSS code (5 digits) and the patient ID code (6 digits).
Data Entry, Continued
Enter all stroke events data (continued)
Step 3
Action Write the whole number in the Identification Number boxes at the top of each page of the patient's completed STEPS Stroke Instrument as follows:
SSS Code Patient ID
Identification Number [ 1 ] [ 1 ] [ 2 ] [ 2 ] [ 0 ] [ 0 ] [ 0 ] [ 0 ] [ 0 ] [ 0 ] [ 1 ]
Write the first 5 digits (the SSS code) of this number on page 1, I 1 of the paper copy of each patient's completed STEPS Stroke Instrument as follows: Patient Identification and Patient Characteristics (I 1) Stroke Surveillance Code [1] [1] [2] [2] [0] When you have recorded the number, Click Ok Enter data into the All Stroke Events window exactly as it is written on the paper Instrument. If Expanded items (grey boxes on the instrument) have been completed on the instrument Then Click the long grey buttons at the bottom of each window to enter expanded data.
5 6 7
8 9
10
Click the Next button to move to the next window, or Back to edit a previous window. Log in a spreadsheet or notebook all discrepancies, questions and problems (irregularities) that you cannot resolve. Include: patient id number instrument code number (eg. i 14) comment. Click close when you have completed entering the All Stroke Events data.
Data Entry, Continued
Entering Step 1, Step 2 and Step 3 data
After entering the All Stroke Events data, you will come to the Selection window. Step 1 Description Click the appropriate button to enter each Step covered by the study as follows. Step 1 2 3 2 Description Events admitted to hospital Fatal events in the community Non-fatal events in the community
When data entry is complete, click the Finish button
Validation and error correction
Before moving to the next patient Instrument, check and resolve any inconsistencies and/or errors noted in the log book or spreadsheet.
Backing up data
The computer used for data entry should be backed up at the end of each week.
Filing the instruments
All completed Instruments that have been entered into the DET should be marked 'entered' on the front page and filed in a secure location.
Data Management
Introduction
To manage the STEPS Stroke data entered using the DET, you may need to perform the following functions: search for a patient record edit data, and delete a patient record.
Search for a patient record
Follow the steps below to search for a patient record. Step 1 2 3 Action Launch the Data Entry Tool from Windows Explorer Click the Search button from the Start window To find a patient record, either enter the patient:
ID number (last 6 digits or the Identification number), or Family name and /or First name A successful search by ID opens the Selection window. A successful search by patient's name opens the Register window where all matches for the entered name are listed. 4 If you searched by patient name, highlight the ID of the correct patient name and click Go to Patient.
Find and edit data
Follow the steps below to find and edit specific patient data. Step 1 Action Select the appropriate button corresponding to the section of the instrument you want to search in the selection window, e.g. All stroke events Step 1 Step 2 Step 3 Choose the Next and Back buttons to find the specific data. Edit the data and close.
2 3
Data Management, Continued
Deleting a patient record
Follow the steps below to delete a patient record. Step 1 2 3 4 Action Launch the Data Entry Tool from Windows Explorer Click the Delete Patient button from the Start window Enter a patient ID and click the Search button. Click Yes to delete the patient record.
Creating Reports
Introduction
You can create and print the following reports from patient data entered into the register using the data entry tool: sex and age distribution stroke subtype distribution.
To create a report
Follow the steps below to create a report. Step 1 2 3 4 5 Action Ensure your printer is connected and on. Launch the Data Entry Tool from Windows Explorer. Click the Reports button from the Start window. Click the type of report you from the Reports window. The selected report will be automatically printed to your printer.
Note: Age distribution (stratified by stroke subtype) can only be calculated after you have created an export file. See Exporting data on page 6-8.
Exporting Data
Introduction
To calculate age distribution (stratified by stroke subtype) or to export the data to other software for statistical analysis, you will have to create an export file.
Procedure
Follow the steps below to create an export file: Step 1 2 3 Action Launch the Data Entry Tool from Windows Explorer. Click the Data Export button from the Start window. Click the button To automatically Complete Create the following text and Excel files of the complete data: AompleteTab.txt CompleteTab.xls Anonymous Make the data anonymous by removing identification details data and create the following text or Excel files for data transfer: AnonymTab.txt AnonymTab.xls 4 Click Close to return to the Start window.
Section 7: STEPS Stroke Instrument and Forms
Introduction
This section provides the generic guidelines for data collection staff.
Purpose
This section provides the STEPS Instrument (version 2.1), and the application form for completion prior to being registered as a Stroke Surveillance Site.
Further guidance
For further guidance on completing data elements in the Instrument, please refer to the date collection guidelines provided in section 5 of the STEPS Stroke Manual.
In this section
This section covers the STEPS Stroke Instrument and the following forms. Topic STEPS Stroke Instrument Application for Participation See Page 7a-1 7b-1
Section 7: STEPS Stroke Instrument V 2.1: Date Last Updated: 9 May 2006
7-1 WHO STEPS Surveillance
Section 7: STEPS Stroke Instrument V 2.1: Date Last Updated: 9 May 2006
IDENTIFICATION NUMBER [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]
WHO STEPS STROKE INSTRUMENT

<INSERT COUNTRY/SITE NAME>
All Stroke Events

For further guidance on All Stroke Events, see Section 5, page 5-15
Patient Identification and Patient Characteristics (I 1) (I 2) (I 3) Stroke Surveillance Site Code

Insert 1 5 digits of automatically generated code from DET
st
[ ][ ][ ][ ][ ] [ ][ ][ ] [ ][ ]/[ ][ ]/[ ][ ][ ][ ]
d d m m y y y y
Interviewer Code
Insert code provided by the ICU
Date of completion of the instrument
Patient individual records (I 4) (I 5) (I 6) (I 7) Patients family name

Use CAPITALS, include all names
[_____________________________] [_____________________________] [_____________________________] [_____________________________] [_____________________________]
Patients first name

Use CAPITALS, include all names
Contact phone number

Include area codes (optional)
Contact address
For follow-up questionnaires (optional)
(I 8)
Unique identification number where available

number, PID etc (optional)
[_____________________________]
Contact person of patient

Include contact person who can confirm the living situation of the patient
(I 9) (I 10) (I 11) (I 12)
Contact persons family name Contact persons first name Contact persons phone number Contact persons address
[_____________________________] [_____________________________] [_____________________________] [_____________________________] [_____________________________]
(I 13)
Relationship of contact person to the patient
[_____________________________]
Demographic characteristics (I 14) Date of birth

If date of birth is unknown, enter age [
[ ][ ]/[ ][ ]/[ ][ ][ ][ ] ][ ][ ]
d d m m y y y y
(I 15)
Sex [select one]
Male Female
(1) [ ] (2)
7a- 1
2006-05-09 STEPS Stroke Instrument (V2.1)
(I 16)
What is your [insert relevant ethnic/racial groups defined according to local demographic needs] If other ethnicity, please state [___________]
(I 17)
XX XX XX Other No formal schooling Less than primary school Primary school completed Secondary school completed High school completed College/university completed Post graduate degree Unknown Government employee Non-government employee Self-employee Non-paid Student Homemaker Retired Unemployed Unknown employed
(1) [ ] (2) (3) (4) (1) [ ] (2) (3) (4) (5) (6) (7) (9) (1) [ ] (2) (3) (4) (5) (6) (7) (8) (9)
Socioeconomic status (I 18) What is the highest level of education the person has completed? [select one]
If a person attended a few months of the first year of secondary school but did not complete the year, record primary school completed.
If a person only attended a few years of primary school or never went to school, record no formal schooling
(I 19)
Which of the following best describes the main work status of the person over the last 12 months? [select one]
The purpose of this question is to help answer other questions such as whether treatment, survival and rehabilitation may differ according to employment status
Information on acute stroke event (I 20) (I 21) Date of stroke Enter date of stroke symptoms onset, or first noticed Definitive stroke [select one] If the patient has a definite stroke, has the patient had a previous stroke? [select one]
Ensure accurate stroke diagnosis for previous stroke events
[ ][ ]/[ ][ ]/[ ][ ][ ][ ]
d d m m y y y y
Yes No Insufficient data Yes, records seen Yes, records not seen No, records seen No, records not seen Insufficient data Yes No Insufficient data
(1) [ ] (2) (3) (1) [ ] (2) (3) (4) (5) (1) [ ] (2) (3)
(I 22)
(I 23)
If the patient has a definite stroke, is this the first stroke in the study period? [select one]
(I 24)
If a subsequent stroke occurred (more than 28 days from the previous stroke), give date of subsequent event [ ] [ ] / [ ] [ ] / [ ] [ ] [ ] [ ]
Enter date of stroke symptoms onset, or first noticed
OPTIONAL items (to be defined by centres; see comments section 3-10) (O 1) (O 2) XX XX [_____________________________] [_____________________________]
7a- 2
Stroke Events Admitted To Hospital (Step 1)

For further guidance on Step 1, Events Admitted to Hospital; see Section 5, page 5-17
Hospital admission (S1 1) Date of admission to hospital

If in-hospital stroke, insert day of hospitalization from primary disease
[ ][ ]/[ ][ ]/[ ][ ][ ][ ] d d m m y y y y [ [ [ [ [ [ [ ] ] ] ] ] ] ]
(S1 2)
Which department(s)/ unit(s) was the patient treated in? Intensive care unit [insert 1 for YES, 0 for NO, or 9 for UNKNOWN] Medical unit If the patient was treated in several units, list all. If Unknown, enter 9 Neurological unit Neurosurgical unit Rehabilitation unit Stroke unit Other What was the living situation of the patient pre stroke? Independent at home [select one] Dependent at home If in-hospital stroke patient, insert living situation prior to hospitalisation Community facility Modified Rankin scale prior to stroke [select one]
See Section 5, page 21 of the Stroke manual for further details on the Modified Rankin Scale.
(S1 3)
(1) [ ] (2) (3)
(S1 4)
No symptoms at all (0) [ ] No significant disability despite symptoms (1) Slight disability (2) Moderate disability, but able to walk without assistance (3) Moderate disability, but unable to walk without assistance (4) Severe disability (5) Unknown (9) Disturbed consciousness Weakness/ paresis Speech disturbances [ ] [ ] [ ]
(S1 5)
Which of following neurological signs were present at first medical examination after hospitalization? [insert 1 for YES, 0 for NO, or 9 for UNKNOWN]
Insert 1 if neurological sign was present at first medical examination 0 if sign was not present and 9 if Unknown.
Stroke classification (S1 6) What subtype of stroke was diagnosed? [select one]
See Section 1, page 6 for explanation of different types of stroke.
Ischemic stroke Intracerebral hemorrhage Subarachnoid hemorrhage Unspecified type
(1) [ ] (2) (3) (4)
7a- 3
Stroke classification contd. (S1 7) How was the diagnosis of stroke subtype verified? [select one] Which of the following diagnostic examinations were performed? [insert 1 for YES, 0 for NO, or 9 for UNKNOWN] Clinical diagnosis alone By diagnostic techniques Angiography Carotid Ultrasound CT scanning Electrocardiogram Lumbar puncture Medical autopsy MRI scanning Other Within 24 hours Between 24 h and 7 days Between 8 to 14 days More than 14 days Does not apply Unknown (1) [ ] (2) [ [ [ [ [ [ [ [ ] ] ] ] ] ] ] ]
(S1 8)
(S1 9)
If scanning was performed, what was the timing of the first scan after onset of stroke symptoms? [select one]
Timing of the first scan after stroke onset is critical. Delays beyond 2 weeks may lead to a re-absorption of small haemorrhagic stroke causing the event to be misclassified as ischemic stroke.
(1) [ ] (2) (3) (4) (5) (9)
Vascular risk factors (S1 10) Which of the following vascular risk factors were noted for the patient? [insert 1 for YES, 0 for NO, or 9 for UNKNOWN]
See Section 5, page 20 for further details on risk factors.
Atrial fibrillation Current tobacco use Diabetes mellitus Hypercholesterolemia Hypertension
[ [ [ [ [
] ] ] ] ]
Medical treatment/ secondary prevention (S1 11) Did the patient receive one or more of the following medications while in hospital? [insert 1 for YES, 0 for NO, or 9 for UNKNOWN]
See Section 5, page 21 for further details on medical treatment.
Anticoagulant drugs Antiplatelet drugs Thrombolysis Others
[ [ [ [
] ] ] ]
(S1 12) Did the patient receive one or more of the following medications at discharge from hospital? [insert 1 for YES, 0 for NO, or 9 for UNKNOWN]
Anticoagulant drugs Antidiabetic drugs Antiplatelet drugs Cholesterol lowering drugs Tablets for high blood pressure Others
[ [ [ [ [ [
] ] ] ] ] ]
7a- 4
In-hospital assessment (S1 13) Which of the following assessments were done during the patients stay in hospital? [insert 1 for YES, 0 for NO, or 9 for UNKNOWN]
Refers to assessments during hospitalization irrespective of whether the Patient was treated or not after the first visit.
Seen by occupational therapist Seen by physiotherapist Seen by speech therapist Swallowing assessment
[ [ [ [
] ] ] ]
Complications during hospitalization (S1 14) Which of the following complications occurred during the patients stay in hospital? [insert 1 for YES, 0 for NO, or 9 for UNKNOWN] Deep venous thrombosis Other CV complication Pneumonia [ ] [ ] [ ]
Discharge from hospital (S1 15) What was the vital status at discharge? [select one] (S1 16) If patient died in hospital, indicate day of death
This date is required to calculate early survival rates.
Patient alive Patient dead
(1) [ ] (2)
[ ][ ]/[ ][ ]/[ ][ ][ ][ ] d d m m y y y y [ ][ ]/[ ][ ]/[ ][ ][ ][ ] d d m m y y y y Home Other hospital/ other ward Community facility Unknown (1) [ ] (2) (3) (9)
(S1 17) If patient alive at discharge, indicate date of discharge

This date is required to calculate survival rates and length of hospital stay.
(S1 18) If patient alive at discharge, what was the discharge destination of the patient? [select one]
See Section 5, page 21 for further details
(S1 19) If patient alive at discharge, Modified Rankin scale at discharge [select one]
See Section 5, page 22 for further details.
No symptoms at all (0) [ ] No significant disability despite symptoms (1) Slight disability (2) Moderate disability, but able to walk without assistance (3) Moderate disability, but unable to walk without assistance (4) Severe disability (5) Unknown (9)
7a- 5
Follow up at 28 day after stroke onset (Optional) (F 1) Was it possible to follow up the patient at day 28? [select one]
See Section 5, page 16 for further details
Yes No, no contact No, patient refused
(1) [ ] (2) (3)
(F 2)
If patient was followed up, indicate date of follow up
[ ][ ]/[ ][ ]/[ ][ ][ ][ ] d d m m y y y y Medical records only Physical examination Telephone interview Postal follow up Other Does not apply (1) [ ] (2) (3) (4) (5) (6)
(F 3)
How was the 28d follow up of the patient performed? [select one]
See Section 5, page 21 for further details Use "does not apply" for patients that died within the first 28 days, refused participation or could not be contacted.
(F 4)
What is the vital status at day 28? [select one]

Use "unknown" if no follow-up was performed
Patient alive Patient dead Unknown
(1) [ ] (2) (9)
(F 5)
If patient dead at day 28 indicate day of death
[ ][ ]/[ ][ ]/[ ][ ][ ][ ] d d m m y y y y
(F 6)
If the patient alive at day 28, what is the living situation of the patient at day 28? [select one]
Home Community facility Still in hospital
(1) [ ] (2) (3)
(F 7)
If patient alive at day 28, Modified Rankin scale at day 28 [select one]
No symptoms at all (0) [ ] No significant disability despite symptoms (1) Slight disability (2) Moderate disability, but able to walk without assistance (3) Moderate disability, but unable to walk without assistance (4) Severe disability (5) Unknown (9)
7a- 6
Fatal Stroke Events in the Community (Step 2)

For further guidance on Step 2, Fatal Events in the Community; see Section 5, page 5-23
(S2 1)
Indicate date of death
[ ][ ]/[ ][ ]/[ ][ ][ ][ ] d d m m y y y y
(S2 2)
How was the patient managed in community from stroke onset until death? [select one]
In nursing home At home by doctor Other medical consultation Medically unattended Insufficient data
(1) [ ] (2) (3) (4) (5)
(S2 3)
How was the information about fatal stroke events in the community collected? [select one]
See Section 5, page 5 or further details these methods
Verbal autopsy Death certificate Medical autopsy ICD 8 System ICD 9 System ICD 10 System No ICD System
(1) [ ] (2) (3) (1) [ ] (2) (3) (4)
(S2 4)
If information was derived from death certificate which International Disease Classification (ICD) System was used? [select one]
See Section 5, page 23 for further details on the ICD system
(S2 5) (S2 6)
If ICD System was used, indicate ICD code

See Section 5, page 23 for further details on ICD codes
[_____________________________] Ischemic stroke Intracerebral hemorrhage Subarachnoid hemorrhage Unspecified type (1) [ ] (2) (3) (4)
If a medical autopsy was performed, what subtype of stroke was diagnosed? [select one]
7a-8
Non-Fatal Stroke Events in the Community (Step 3)

For further guidance on Step 3, Non-Fatal Events in the Community; see Section 5, page 5-24
(S3 1)
How was the patient managed in community? [select one]
In nursing home Medically unattended At home by doctor or nurse Other medical consultation Insufficient data Survey of health facilities Survey of hemiplegia
(1) [ ] (2) (3) (4) (5) (1) [ ] (2)
(S3 2)
How was the information about the non-fatal stroke event in the community collected? [select one] What subtype of stroke was diagnosed? [select one]
See Section 1, page 6 for further information on stroke subtypes
(S3 3)
Ischemic stroke Intracerebral hemorrhage Subarachnoid hemorrhage Unspecified type Clinical diagnosis alone By diagnostic techniques
(1) [ ] (2) (3) (4) (1) [ ] (2) (1) [ ] (2) (3) (9) [ [ [ [ [ [ ] ] ] ] ] ]
(S3 4)
How was the diagnosis of stroke subtype verified? [select one]
(S3 5)
What was the living situation of the patient pre stroke? Independent at home [select one] Dependent at home Community facility Unknown Did the patient receive one or more of the following medications [insert 1 for YES, 0 for NO, or 9 for UNKNOWN]
(S3 6)
Anticoagulant drugs Antidiabetic drugs Antiplatelet drugs Cholesterol lowering drugs Tablets for high blood pressure Others
7a-8
STEPS Stroke Application for Participation

Introduction
This form registers an expression of interest in participating in WHO STEPS Stroke and provides the ICC with background information on the planned stroke surveillance site.
Name of SSS
Site coordinator Contact details Title Name (family) Name (first) Institution Mail address City, Country Postal code Telephone Fax E-mail
Other details
Please provide brief details of your experience in cerebrovascular disease and other details relating to data management: Type Clinical Research Epidemiologic Other Previous experience (please tick or give brief details)
Data management Are computers available for data entry ? Do you have software licence for MicroSoft Access? Which version of MicroSoft Assess do you have? Is secure storage of original and electronic data possible? Do you take responsibility for all data entered? Do you have access to a data analyst?
Yes
No
2006-05-09 Please send to WHO STEPS ICC [email protected] or Fax +41 22 791 4767
7b-1
Ethical and legal issues Does the site coordinator take responsibility for all ethical and legal issues related to the study (including approval from local ethics committee, insurance for staff members, providing informed consent, data security etc)? Financial support Have you obtained financial support to cover all expenses Related to the study? Please state the kind of financial support (in kind, Grant etc):
Yes
No
Access to routine DCs
Do you have access to routine death certificates? Please give details on how you plan to verify potential stroke deaths. Please provide details of proposed duration Study duration Start date of Registration Duration - one off register 12 months Duration - ongoing register Duration - other (provide details Planned Start date (first enrolled patient) Please tick
Study duration
Proposed design
Indicate which of the following study designs is planned: Please tick Estimated # of stroke patients per year
Study design Hospital register - case series only Hospital register - with population denominator Population based incidence study
Note: for meaningful analyses by age and sex, a minimum of 250 per year is required
Case finding
Please provide details of planned case finding methods (including frequency)
Hot pursuit Cold pursuit Mixed pursuit Frequency
7b-2
Hospital registers
Please list all health facilities to be included in the proposed Stroke Surveillance Site Type No. Wards (No. beds) Est # stroke cases per week Brain imaging available? (please tick)
Hospital Name
Population based registers
If data are available from the source population from which all eligible stroke cases (Hospital register - step 1; or Incidence study - Steps 1-3), please complete:
Age group (yrs) 0 - 14 15 - 24 25 34 35 44 45 54 55 64 65 - 74 75 - 84 85 94 95 or more Total

Population
Instrument coverage Optional Expanded Expanded Expanded Core Core Core Core Expanded Optional
Men
Women
Total
Which of the following provides the information for your defined population? Date of info
Source Census Intercensal estimate Household registers Other population based register (eg cancer) Other (briefly explain)
Final STEPS Instrument
Please send a copy of the planned instrument to be used in your site. This should include expanded items (and any optional items if you require feedback on format).
Signature
Date:
7b-3
Section 8: Glossary and Reference Material
Introduction
This section provides an alphabetical list of all the terms used in a STEPS surveillance with definitions that are appropriate for STEPS and a list of all the source and reference material used to compile this manual.
In this section
This section covers the following topics. Topic Glossary of Terms used in STEPS Stroke Source Publications and References See Page 8-2 8-3
Section 8: Glossary and Reference Material V 2.1: Date Last Updated: 9 May 2006
Glossary of Terms used in STEPS Stroke
Term Amaurosis fugax Apraxia Ataxia Bilateral Case-fatality Contra-lateral Demography Diplopia Dysarthria Dysphagia Dysphasia Hemiplegia Homonymous hemianopia Incidence
Intracerebral hemorrhage Ischemic stroke Modified Rankin Scale Morbidity Mortality Prevalence Stroke
Definition Periodical blindness of an eye due to embolic occlusion of the artery supplying the retina. The inability to execute a planned motor act in the absence of paralysis of the muscles normally used in the performance of the act. Co-ordination disturbances. Includes both sides of the body. The proportion of events which are fatal within a given period of time. Refers to the opposite side of the body. The composition of the population. Double vision. A defect in the articulation of the speech. Impaired ability to swallow. Difficulty with comprehension or production of the language despite intact articulation and phonation. Weakness of the arm and leg on one side of the body. Loss of vision in one half of the visual field. Lesions of the optic nerve behind the chiasm produce contra-lateral visual field deficits. The incidence of stroke is the number of new cases of stroke arising in a given period in a defined population: usually expressed as a rate per 100,000. Incidence gives an indication of the risk of stroke. Bleeding from intracerebral arteries and may cause stroke symptoms. Stroke symptoms known to originate from an occlusion of cerebral arteries. A scale that indicates the level of handicap in a person. A rate of how many people get sick per person years. A rate of how many people die per person years. Prevalence is the number of cases in a defined population at a specified point in time - gives a "snapshot" of survivors at any one time A clinical diagnosis based on recognisable clinical symptoms indicating a vascular cause of sudden onset of neurological deficits. For definition please see page 1-4. A bleeding from intra cranial arteries leading to blood between two membranes that surround the brain. Ongoing, continuous collection of epidemiologic data in a population. Sudden neurologic deficits that lasts less than 24 hours, and with full recovery. Restricted to one side of the body. A false sense of rotary movement of self or surrounding objects. May be associated with nausea and vomiting.
Subarachnoid hemorrhage Surveillance Transient Ischemic Attack (TIA) Unilateral Vertigo
Source Publications and References
Introduction
This section provides an alphabetical list of : References used in this publication Resources available from the STEPS team
References
This section provides an alphabetical list of references and sources used. Anderson C, Carter, K, Hackett M, Feigen V, Barber, A, Broad J, Bonita R. Trends in stroke incidence in Auckland, New Zealand, between 1981 and 2003. Stroke 2005; 36:2087. Armstrong T, Bonita R. Building capacity for an integrated noncommunicable disease risk factor surveillance system in developing countries. Ethnicity and Disease 2003;13(s)2 Asplund K, Bonita, Kuulasmaa, Rajakangas A-M, Feigin V, Schaedlich H, Suzuki K, Thorvaldsen P, Tuomilehto J; for the WHO MONICA project. Multinational comparisons of stroke epidemiology: evaluation of case ascertainment in the WHO MONICA Stroke Study. Stroke 1995;26:355-60 Asplund, K., Rajakangas, A., Kuulasmaa, K., Thorvaldsen, P., Bonita, R., Stegmayr, B., Suzuki, K., and Eisenbltter, D. WHO MONICA Project: Multinational comparison of diagnostic procedures and management of acute stroke. Cerebrovasc Dis 1996; 6: 66-74. Adams HP Jr, Adams R, Adams RJ, Brott T, Brott TF, del Zoppo GJ, Furlan et al. Guidelines for the early management of patients with ischemic stroke: A scientific statement from the Stroke Council of the American Stroke Association. Stroke 2003; 34:1056-83. Bonita R, Mendis S, Truelsen T, Bogousslavsky J, Toole J, Yatsu F. The Global Stroke Initiative. Lancet Neurology. 2004;3:391-93 Bonita R, Truelsen T. Stroke in Sub Saharan Africa: a neglected chronic disease. Lancet Neurology. 2003; 2: 592-4. Bonita, R; Douglas, K; Winkelmann, R; De Courten, M; The WHO STEPwise approach to surveillance (STEPS) of noncommunicable disease risk factors. Chapter in (eds) McQueen, DV and Puska, P (editors); Global Risk Factor Surveillance. London: Kluwer Academic/Plenum Publishers, New York. 2003; pp 9-22
Source Publications and References, Continued
Bonita, R; Truelsen, T. Edited by Barnett, H.J.M; Bogousslavsky, J, Meldrum, H. Advances in Ischemic Stroke Epidemiology. Chapter in Ischemic Stroke: Advances in Neurology. Vol 92. Lippincott Williams & Wilkins, Philadelphia 2003 Bonita, R; Strong, K; De Courten, M.; From surveys to surveillance. Rev Panam Salud Publica/Pan Am J Public Health; 2001; 10: 223225 Bonita R, Broad JB, Anderson NE, and Beaglehole R. Approaches to the problems of measuring the incidence of stroke. Int J Epidemiol 1995;24: 535-542. Bharucha, NE, Bharucha, EP, Bharucha AE, Bhise AV, Schoenberg BS.. Prevalence of stroke in the parsi community of Bombay. Stroke 1998; 19: 60-62. Choi B, Corber, McQueen D, Bonita R et al. Enhancing regional capacity in chronic disease surveillance in the Americas. Rev Panam Salud Publica/ Pan Am J Public Health 2005;17: 130-141. Prospective studies collaboration. Cholesterol, diastolic blood pressure, and stroke: 13,000 strokes in 450,000 people in 45 prospective cohorts. - Lancet 1995; 346:1647-53. Collins RF, Armitage JF, Parish S, Sleight P, Sleight PF, Peto R. - Effects of cholesterol-lowering with simvastatin on stroke and other major vascular events in 20536 people with cerebrovascular disease or other high-risk conditions. - Lancet 2004; 363:757-67. Chandramohan D, Maude GH, Rodrigues LC, and Hayes RJ. Verbal autopsies for adult deaths: issues in their development and validation. Int J Epidemiol 1994; 23: 213-222. Dennis MS, Bamford JM, Molyneux AJ, and Warlow CP. Rapid resolution of signs of primary intracerebral haemorrhage in computed tomograms of the brain. BMJ 1987; 295:379-381. Dhamija RK, Mittal S, and Bansal BC. Trends in clinico-epidemiological correlates of stroke in the community. J Indian Academy Clin Med. 2000;5:27-31 . Doggett DL, Tappe KA, Mitchell MD, Chapell RF, Coates VF, Turkelson CM. Prevention of pneumonia in elderly stroke patients by systematic diagnosis and treatment of dysphagia: an evidence-based comprehensive analysis of the literature. Dysphagia 2001; 16:279-95.
D'Olhaberriague LF, Litvan IF, Mitsias PF, Mansbach HH. A reappraisal of reliability and validity studies in stroke. Stroke 1996; 27:2331-6. Donnan GA - Davis S, Davis SM. Stroke and cholesterol: weakness of risk versus strength of therapy. Stroke 2004; 35:1526. Feng J H, Nowson CA, MacGregor GA. Fruit and vegetable consumption and stroke: a met analyses of cohort studies. Lancet 2006; 367:320-326 Feigin VL, Carter K. Editorial comment. Stroke incidence studies one step closer to the elusive gold standard? Stroke. 2004; 35: 2045-7. Feigin V, Brainin M, Breteler MMB, Marytn C, Wolfe C, Bornstein N. Fieschi C et al . Teaching in neuro epidemiology in Europe: Time to get serious. Eur J Neurology; 2004; 11:795-9 Feigin VL, Lawes CM, Bennett DA, Anderson CS. Stroke epidemiology: a review of population-based studies of incidence, prevalence, and casefatality in the late 20th century. Lancet Neurol. 2003; 2: 43-53. Review. Foerch C, Misselwitz B, Sitzer M, Berger K, Steinmetz H, NeumannHaefelin T. Difference in recognition of right and left hemispheric stroke. Lancet 2005; 366: 392-393. Hatano S. Experience from a multi centre stroke register: a preliminary report. Bull WHO 1975; 54:541-553. Heuschmann PU, Kolominsky-Rabas P, Kolominsky-Rabas PL, Roether J, Roether JF, Misselwitz BF, Lowitzsch KF, et al. - Predictors of in-hospital mortality in patients with acute ischemic stroke treated with thrombolytic therapy. JAMA 2004; 292:1831-8. Heuschmann PU, Kolominsky-Rabas P, - Kolominsky-Rabas PL FAU, Misselwitz B, Misselwitz BF, Hermanek PF, Leffmann CF, et al. Predictors of in-hospital mortality and attributable risks of death after ischemic stroke: the German Stroke Registers Study Group. - Arch Intern Med 2004 13; 164:1761-8. Katzan IL, Cebul RD FAU, Husak SH, Dawson NV, Baker DW. - The effect of pneumonia on mortality among patients hospitalized for acute stroke. - Neurology 2003; 60:620-5. Lavados PM, Sacks C, Prina L, Escobar A, Tossi C, Araya F, Feuerhake W, Galvez M, Salinas R, Alvarez G. Incidence, 30 day case-fatality rates and prognosis of stroke in Iquique, Chile (PISCIS project). Lancet 2005;365,:2206-2215
Section 8: Glossary and Reference Material V 2.1: Date Last Updated: 9 May 2006 8-5 WHO STEPS Surveillance
Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. - BMJ 2003; 326:1423. Murray CJL and Lopez AD. Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet. 1997; 349, 1269-1276. Nicoletti A, Sofia V, Giuffrida S, Bartoloni A, Bartalesi F, Bartolo MLL, Fermo SL, Cocuzza V, Gamboa H, Salazar E, and Reggio A. Prevalence of stroke. A door-to-door survey in rural Bolivia. Stroke 2000;31: 882-885. Nor AM, Davis J, Sen B, Shipsey D, Louw SJ, Dyker AG, Davis M, Ford GA. The Recognition of Stroke in the Emergency Room (ROSIER) scale: development and validation of a stroke recognition instrument. Lancet Neurology. 2005; 4:727-734. Pandian JD, Jaison A, Sukhbinder SD, Kalra G, Shamsher S, Lincoln DJ, Abraham G. Public awareness of warning symptoms, risk factors, and treatment of stroke in Northwest India. Stroke 2005; 36: 644-648. Pendlebury ST, Rothwell PM, Algra A, Ariesen M-J, Bakac G. Czlonkowska A, et al. Underfunding of stroke research: a European wide problem. Stroke 2004; 35:2368-71 Poungvarin N. Stroke in the developing world. Lancet 1998; 35:19-22. Piechowski-Jozwiak BF, Bogousslavsky J. Cholesterol as a risk factor for stroke: the fugitive? Stroke 2004;35:1523 Reed SD, Cramer SC, Blough DK, Meyer KF, Jarvik JG. - Treatment with tissue plasminogen activator and inpatient mortality rates for patients with ischemic stroke treated in community hospitals. Stroke 2001; 32:1832-40. Rothwell P, Coull A, Silver L, Fairhead J, Giles M, Lovelock C, Redgrave J, et al. Population-based study of event-rate, incidence, case fatality, and mortality for all acute vascular events in all arterial territories (Oxford Vascular Study) Lancet. 2005; 366: 1773-1783. Sacco RL, Benjamin EJ FAU, Broderick JP FAU, Dyken MF, Easton JD, Feinberg WM et al. - AHAPrevention Conference. IV. Prevention and Rehabilitation of Stroke. Risk factors. - Stroke 1997; 28:1507-17. Setel PW, Sankoh O, Rao C, Velkoff VV, Mathers, Gonghuan Z, Hemed et al. Sample registration of vital events with verbal autopsy. A renewed commitment to measuring and monitoring vital statistics. Bulletin WHO 2005; 83: 611-17.
Section 8: Glossary and Reference Material V 2.1: Date Last Updated: 9 May 2006 8-6 WHO STEPS Surveillance
Straus SE, Majumdar S, Majumdar SR, McAlister F, McAlister FA. New evidence for stroke prevention: clinical applications. JAMA 2002;288:1396-98. Stroke Unit Trialists' Collaboration. Collaborative systematic review of the randomized trials of organized inpatient (stroke unit) care after stroke. BMJ 1997;314: 1151-1159. Struijs JN, van Genugten ML, Evers SM, Ament AJ, Baan CA, van den Bos GA. Modelling the future burden of stroke in The Netherlands: impact of aging, smoking, and hypertension. Stroke 2005; 36:1648-55. Sudlow CL, Warlow CP. Comparable studies of the incidence of stroke and its pathological types: results from an international collaboration. International Stroke Incidence Collaboration. Stroke. 1997; 28:491-9. Thorvaldsen P, Asplund K, Kuulasmaa K, Rajakangas A-M, Schroll M; for the WHO MONICA Project. Stroke, 1995;26: 361-67. Truelsen T, Bonita R. Surveillance of Stroke: A Global Perspective. Int J Epidemiol 2001: 30; Suppl 1: S11-S16 Truelsen T, Mhnen M, Tolonen H, Asplund K, Bonita R, Vanuzzo D, for the WHO MONICA Project: Trends in Stroke and Coronary Heart Disease in the WHO MONICA Project. Stroke, JAMA. 2003; 34: 1346-1352. UK TIA Study Group. The United Kingdom transient ischaemic attack (UK TIA). Aspirin Trial: Final results. J Neurol Neurosurg Psychiatry. 1991; 54:1044-1054. Walker RW, McLarty DG, Kitange HM, Whiting D, Masuki G, Mtasiwa DM, Machibya H, Unwin N, and Alberti KGMM. Stroke mortality in urban and rural Tanzania. Lancet 2000;355:1684 Weir NU, Sandercock PA FAU, Lewis SC FAU, Signorini DF, Warlow CP. Variations between countries in outcome after stroke in the International Stroke Trial (IST). - Stroke 2001; 32:1370-7. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med 1987; 147:1561-4 Wolfe CD, Tilling KF, Beech RF, Rudd AG. - Variations in case fatality and dependency from stroke in western and central Europe. The European BIOMED Study of Stroke Care Group. - Stroke 1999; 30:350-6.

The Who Stepwise Approach To Stroke Surveillance

Uploaded by

Copyright:

Available Formats

The Who Stepwise Approach To Stroke Surveillance

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

The Who Stepwise Approach To Stroke Surveillance

Uploaded by

Copyright:

Available Formats

The WHO STEPwise approach to stroke surveillance

WHO STEPS Stroke Manual

Continued on next page

STEPS Stroke Surveillance Manual (V2.1) 2006-05-09

Table of Contents, Continued

STEPS Stroke Surveillance Manual (V2.1) 2006-05-09

Section 1: Introduction Overview

This section is an introduction to the STEPS Stroke Surveillance Manual.

Guide to using the manual

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-1 STEPS Stroke Surveillance

Rationale for Stroke Surveillance

Purpose of STEPS stroke surveillance

Rationale for surveillance

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-2 STEPS Stroke Surveillance

Rationale for Stroke Surveillance, Continued

Other expected outcomes

Surveillance: key to prevention

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-3 STEPS Stroke Surveillance

Standard WHO definition

Notes on the standard definition

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-4 STEPS Stroke Surveillance

About Stroke, Continued

Type Ischemic stroke

Neuro imaging, or Lumbar puncture.

General major symptoms

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-5 STEPS Stroke Surveillance

About Stroke, Continued

Stroke like symptoms

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-6 STEPS Stroke Surveillance

About Stroke, Continued

Types of stroke events

First ever stroke events

Recurrent stroke events

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-7 STEPS Stroke Surveillance

Major Risk Factors

Major risk factors

Other risk factors

Key sources on information on country level risk factors

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-8 STEPS Stroke Surveillance

In-hospital Management and Facilities

In-hospital management refers to stroke patients admitted to a health facility.

Specialist stroke teams

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-9 STEPS Stroke Surveillance

Overview of STEPS Stroke

Basis of STEPS Stroke

STEPS Stroke diagram

From Case series

Section 1: Introduction V 2.1: Date Last Updated: 9 May 2006

1-10 STEPS Stroke Surveillance

Overview of STEPS Stroke, Continued