Method
General
Riksstroke is the national quality register for stroke care in Sweden and one of the largest of the many quality assessment registers in the country1,2. It was initiated in 1994 with the primary aim to monitor and improve the quality of stroke care and research. Since 1998 the register includes all hospitals admitting patients with acute stroke in Sweden.
Riksstroke is governed by a Steering Group with members representing expertise in stroke care (neurology, internal medicine, geriatrics, nursing, physiotherapy), epidemiology and administration. The Swedish patient stroke association is also represented in the Steering Group.
The Riksstroke Coordinating Centre includes coordinating nurses, statisticians and a data manager. The centre collects data from and provides support and structured feedback to the hospitals participating in Riksstroke, performs quality controls and validations, coordinates the work performed at a supporting computer centre, performs analyses and produces annual reports. It also supports scientific work based on Riksstroke data.
Feed-back is provided annually to each participating hospital. Emphasis is on performance relative to other hospitals and time trends. Four to six reports are published yearly, in which Riksstroke data from the 21 counties and the 72 hospitals admitting acute stroke patients are compared. These comparisons are publically available in print and at the Riksstroke website. Key quality indicators from the Riksstroke register are also included in an annual presentation of the quality of Swedish healthcare with open comparisons between counties and hospitals3.
Riksstroke is funded by a grant from The Swedish Government and the Swedish Society and the Federation of Swedish County Councils. Research projects based on Riksstroke data are funded separately from public, non-profit and commercial sources; information is given in the publications.
Eligibility
Patients diagnosed with ischemic stroke (ICD-10 I63), intracerebral haemorrhage (ICD-10 I61) or unspecified acute cerebrovascular event (ICD-10 I64) are eligible for registration in Riksstroke. Individual hospitals may also choose to record additional stroke diagnoses (ICD-10 I60-I69) but these not included in the annual reports of Riksstroke or in the feed-back information provided to the participating hospitals.
From 2010 patients with transitory ischemic attack and amaurosis fugax (ICD-10 G45) are also registered in a similar but slimmer version compared with acute stroke cases.
Information included in Riksstroke
For each individual patient, a case record is used to collect data before onset, during the hospital stay and at discharge, and a separate record is used for a 3-months and 12 month follow-up. English versions of the case records are available at http://www.riksstroke.org/forms/
The register includes information on several dimensions of stroke care. The information is collected selected with the following principles in mind:
- The entire chain of stroke care should be covered, i.e. primary prevention, acute management, rehabilitation, secondary prevention and family and community support.
- Both process and outcome variables are included.
- The six dimensions of healthcare quality defined by the US Institute of Medicine should ideally be encompassed: health care should be evidence-based, safe, provided in time, distributed fairly, patient-oriented and cost-effective 4.
To analyse processes and outcomes in relation to case-mix, a number of background variables are recorded. They include information on living conditions, whether the person is married/cohabitant or living alone, primary activity in daily living (ADL) functions before stroke, a history of previous stroke and co-morbidity. The Riksstroke´s ADL instrument, also used at the 3-months follow-up, is described below under the heading Validation studies.
Level of consciousness on admission to hospital is recorded using three levels based on the Reaction Level Scale (RLS 85) 5. Patients with RLS 1 are defined as alert, RLS 2-3 as drowsy and RLS 4-8 as unconscious. The RLS is widely used in Swedish healthcare and has been shown to predict outcome at least as well as the Glasgow Coma Scale in patients at risk of developing impaired brain function 6-8.
Stroke severity at hospital arrival, as measured by the NIH Stroke Scale9, 10 , was introduced in 2007.
Items related to acute management of stroke include time from onset of stroke symptoms to arrival in hospital, diagnostic procedures and medical treatment. Information on care facilities includes type of department (neurological, medical, geriatrics/rehabilitation medicine or other), admission to stroke unit, general ward, admission/observation ward, intensive care or other ward, and transfer between wards/departments during the acute hospital stay. Information on where the patient is discharged (home or various institutional settings) is also included.
Three months after stroke, the patients are contacted by staff at the hospital they have been treated in and asked to answer a questionnaire either by telephone or mail or by a return visit. Information on the patients living arrangement, dependency in primary ADL, satisfaction with hospital care and rehabilitation, need for support, perceived support, problems with speech, self-reported depression and patient-perceived general health and quality of life using the are included in this 3-month follow-up.
From 2015, the ADL items will be congruent with the modified Rankin Scale. For patients unable to respond themselves, family members or, if the patient is cared for in an institution, staff members are asked to complete the questionnaire on behalf of the patients.
Chart below shows the proportion of follow-up information obtained by different responders (2011-2013).
Ethical considerations
Riksstroke has been approved by the Regional Ethical Review Board at Umeå University and the data-handling procedures by the National Computer Data Inspection Board. For some specific research questions and for linkage to other registers, separate approvals have been obtained.
All included patients have been informed about registration in Riksstroke. An opt-out procedure for registration is used. Thus, patients are informed that they can deny participation or they can ask that their data be withdrawn at any time.
References
1. Anonymous. Quality registers. Available at http://www.kvalitetsregister.se/index.php?option=com_content&task=view&id=63&itemid=592. 2009
2. Sveriges Kommuner och Landsting. Nationella kvalitetsregister inom hälso- och sjukvården 2007 [National quality registers in healthcare 2007; in Swedish]. Available at http://www.kvalitetsregister.se/images/stories/documents/bla_boken_2007.pdf; 2008.
3. Swedish Associations of Local Authorities and Regions and National Board of Health and Welfare. Quality and efficiency in Swedish health care. Stockholm; 2008.
4. Committe on the Quality of Health Care in America. Crossing the quality chasm: A new health system for the 21st century. Waskington, D.C.: Institute of Medicine; 2001.
5. Starmark JE, Stalhammar D, Holmgren E. The reaction level scale (RLS85). Manual and guidelines. Acta Neurochir (Wien). 1988;91:12-20
6. Starmark JE, Stalhammar D, Holmgren E, Rosander B. A comparison of the Glasgow coma scale and the reaction level scale (RLS85). J Neurosurg. 1988;69:699-706
7. Tesseris J, Pantazidis N, Routsi C, Fragoulakis D. A comparative study of the reaction level scale (RLS85) with Glasgow coma scale (GCS) and Edinburgh-2 coma scale (modified) (E2CS(m)). Acta Neurochir (Wien). 1991;110:65-76
8. Walther SM, Jonasson U, Gill H. Comparison of the Glasgow coma scale and the reaction level scale for assessment of cerebral responsiveness in the critically ill. Intensive Care Med. 2003;29:933-938
9. Goldstein LB, Bertels C, Davis JN. Interrater reliability of the nih stroke scale. Arch Neurol. 1989;46:660-662
10. Spilker J, Kongable G, Barch C, Braimah J, Brattina P, Daley S, Donnarumma R, Rapp K, Sailor S. Using the nih stroke scale to assess stroke patients. The NINDS rt-pa Stroke Study Group. J Neurosci Nurs. 1997;29:384-392