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Background Vertigo and dizziness are among the most common health problems in medical practice [1, 2, 3, 4, 5]. Vertigo and dizziness include both consequences of disease as well as definable disease entities such as benign paroxysmal positional vertigo, Meniere?s disease, or vestibular migraine.
Irrespective of the various causes and underlying health conditions, vertigo and dizziness have significant impact on functioning and overall quality of life of the affected individuals To give some examples, the most common peripheral-vestibular disorder benign paroxysmal positioning vertigo - which is also the most frequent type of vestibular disorder - causes brief rotatory vertigo attacks, mainly triggered by rapid head movements, e.g. when turning around in the bed or lacing shoes.
Central-peripheral disorders, which may be caused by brain ischemia, multiple sclerosis, or other permanent or transient brain lesions, can make vertigo attacks lasting from minutes to even weeks [6]. In addition, vertigo and dizziness are a considerable burden to economy and health care [4, 7, 8]. Precondition of effective management and treatment of potentially disabling conditions like vertigo is - besides careful diagnosis of the underlying condition -the assessment of outcomes which are relevant to the patient.
This is not only important to monitor treatment effects but also to set goals and to plan therapy [6]. As summarized by Morris et al. [9] outcome measures in vertigo vary by the entities they are addressing, such as subjective experience of disability or signs and symptoms. Most of them reflect either the patients? or health professionals? experience.
As an example, the frequently used Dizziness Handicap Inventory [10] addresses the patients? experience of the consequences of vertigo on daily living. Most outcome measures are developed and validated on the basis of empirical findings or professional experience [11].
However, none of them refer to a common theoretical framework. A theoretical framework is fundamental for defining an Outcome measurement and helps to ensure that the whole potential spectrum of issues is reflected [12]. In addition to the lack of theoretical foundation there is still no agreement on standards used to measure outcomes in patients with vertigo.
This is illustrated by a recently published Cochrane Review in the field of vestibular rehabilitation which noted 15 different outcome measures of patients? complaints in 21 studies [13]. To address both these issues, the Integrated Center for Research and Treatment of Vertigo, Balance and Ocular Motor Disorders ( IFB LMU ) at the Ludwig-Maximilians-Universität in Munich set up a project that aims to develop an international standard for the description of functioning and disability in patients with vertigo and dizziness based on the International Classification of Functioning, Disability and Health (ICF).
With the ICF, which is part of the family of international classifications of the World Health Organisation (WHO), there is a common theoretical framework for describing and measuring health and disability.
The ICF models the individuals' functioning and health as a complex interaction between a health condition.
Vertigo, dizziness and balance disorders have major impact on independence, employability, activities and participation. There are many measures for the assessment of the impact of vertigo, but no consensus exists on which aspects should be measured.
The objective of this study was to develop international standards (ICF Core Sets) for patients with vertigo and dizziness to describe functioning. The development of the ICF Core Sets involved a formal decision-making and consensus process, integrating evidence from preparatory studies including qualitative interviews with patients, a systematic review of the literature, a survey with health professionals, and empirical data collection from patients.
Twenty-seven experts selected 100 second level categories for the comprehensive Core Set and 29 second level categories for the Brief Core Set. The largest number of categories was selected from the ICF component Activities and Participation (40). Twenty-five categories were selected from the component Body Functions, six from Body Structures, and 29 from Environmental Factors.
The ICF Core Set for vertigo is designed for physicians, nurses, therapists and other health professionals working in inpatient or ambulatory settings. ICF Core Sets create patient-relevant outcomes that can be used as evidence for the success of treatments.
Symptom frequency and severity in vestibular disorders often do not correlate well with patients' restrictions of activities of daily living and limitations of participation. Due to the lack of appropriate patient reported outcome measures (PRO), the extent of limitations and restrictions is mostly unknown.
The International Classification of Functioning, Disability and Health (ICF) is a conceptual framework and classification to evaluate all aspects of health and disability. An ICF-based measure, the Vestibular and Participation Measure (VAP), was recently proposed. Also, an ICF Core Set for vertigo, dizziness and balance disorders was developed to describe what aspects of functioning should be measured.
This study protocol describes the development and cross-cultural validation of a new measure, the VAP-extended (VAP-e), based on VAP and ICF Core Set on three continents. To determine objectivity and cross-cultural validity of the VAP and to find potentially redundant items, Rasch models will be used. The VAP-e will be created by modifying or adding items from the Activities and Participation and Environmental Factors component of the ICF Core Set.
Reliability, objectivity and responsiveness of the VAP-e will be tested.