A study to improve the diagnosis of vertigo in general practice
| ISRCTN | ISRCTN97250704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97250704 |
| Secondary identifying numbers | ZonMw 10060022010003 |
- Submission date
- 14/02/2023
- Registration date
- 16/02/2023
- Last edited
- 04/04/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Vertigo is a common symptom that increases with age. The impact for patients is enormous: four out of five patients with vertigo report severely impairing symptoms, leading to sick leave, medical consultation, interruption of daily activities, and/or avoidance of leaving the house. In older patients, vertigo is associated with anxiety, depression, social isolation, and falling. The economic burden is substantial, due to repeated consultations, excessive use of diagnostic imaging, emergency care, and decreased productivity.
More than 80% of the patients with vertigo are primarily treated by their general practitioner (GP) and never referred to a medical specialist. Despite this therapeutic responsibility, the GP’s diagnostic toolkit has serious limitations. All recommended tests lack empirical evidence
because a diagnostic accuracy study on vestibular disease has never been performed in primary care. This scientific gap was identified and highly prioritized by the National General Practice Research Agenda (4.5.6 NERVOUS SYSTEM, ICPC N; priority 3/10; ID 549/554). The VERtigo
DIagnosis study (VERDI, a famous Italian composer who experienced frequent episodes of dizziness and died of stroke) will fill this gap. The researchers will construct a diagnostic algorithm that enables GPs to identify more accurately and efficiently underlying causes in patients with vertigo. This may lead to faster and more targeted treatment, less diagnostic imaging and referral, less prescribing of antivertigo drugs, and improvement of the overall outcome for patients with vertigo in general practice.
The main aim of this study is to investigate the diagnostic accuracy of history taking and physical examination for patients with vertigo in general practice, in order to construct an easy-to-use diagnostic algorithm for daily clinical practice.
The key objectives are:
1. To assess the existing evidence on the accuracy of tests for diagnosing causes of vertigo in general practice
2. To determine which tests should be investigated in a diagnostic accuracy study for patients with vertigo in general practice
3. To investigate the diagnostic accuracy of selected tests for patients with vertigo in general practice
4. To construct an easy-to-use diagnostic algorithm for vertigo in general practice
5. To compare the diagnostic accuracy of GP judgement with the constructed diagnostic algorithm
Who can participate?
Patients aged 18 years and over with a new episode of vertigo presenting in general practice
What does the study involve?
Patients will undergo a battery of diagnostic tests during a home visit.
What are the possible benefits and risks of participating?
With the results of the proposed study patients will faster and more frequently receive an appropriate diagnosis, leading to more adequate treatment and thus potentially improving the outcome of their symptoms.
With the constructed diagnostic algorithm, GPs will be able to more accurately and efficiently identify underlying causes in patients with vertigo. This may lead to faster treatment, more targeted treatment, less use of diagnostic imaging, less referral to secondary/tertiary care, and
an improvement of the overall outcome for patients with vertigo in general practice.
With faster and more accurate diagnoses, patients can often be treated in general practice and expensive additional testing and referral to secondary/tertiary care can be avoided.
The risks of participating in the VERDI study were assessed as 'negligible', which was approved by the Medical Ethics Committee of the Amsterdam UMC.
Where is the study run from?
Amsterdam UMC, location VUmc (Netherlands)
When is the study starting and how long is it expected to run for?
January 2021 to December 2027
Who is funding the study?
ZonMw (Netherlands)
Who is the main contact?
Dr O.R. Maarsingh, o.maarsingh@amsterdamumc.nl
Contact information
Principal Investigator
Boelelaan 1117
Amsterdam
1081HV
Netherlands
 ORCID ID |
0000-0002-3747-9217 |
|---|---|
| Phone | +31 (0)12780287 |
| o.maarsingh@amsterdamumc.nl |
Study information
| Study design | Observational diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Diagnostic accuracy study |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The diagnostic accuracy of history taking and physical examination for patients with vertigo in general practice: the VERDI study |
| Study acronym | VERDI |
| Study objectives | Background Vertigo is a common symptom that increases with age. The impact for patients is enormous: four out of five patients with vertigo report severely impairing symptoms, leading to sick leave, medical consultation, interruption of daily activities, and/or avoidance of leaving the house. In older patients, vertigo is associated with anxiety, depression, social isolation, and falling. The economic burden is substantial, due to repeated consultations, excessive use of diagnostic imaging, emergency care, and decreased productivity. More than 80% of the patients with vertigo are primarily treated by their general practitioner (GP) and never referred to a medical specialist. Despite this therapeutic responsibility, the GP’s diagnostic toolkit has serious limitations. All recommended tests lack empirical evidence, because a diagnostic accuracy study on vestibular disease has never been performed in primary care. This scientific gap was identified and highly prioritized by the National General Practice Research Agenda (4.5.6 NERVOUS SYSTEM, ICPC N; priority 3/10; ID 549/554). The VERtigo DIagnosis study (VERDI, a famous Italian composer who experienced frequent episodes of dizziness and died of stroke) will fill this gap. The researchers will construct a diagnostic algorithm that enables GPs to identify more accurately and efficiently underlying causes in patients with vertigo. This may lead to faster and more targeted treatment, less diagnostic imaging and referral, less prescribing of antivertigo drugs, and improvement of the overall outcome for patients with vertigo in general practice. Main objective To investigate the diagnostic accuracy of history taking and physical examination for patients with vertigo in general practice, in order to construct an easy-to-use diagnostic algorithm for daily clinical practice. Key objectives 1. To assess the existing evidence on the accuracy of tests for diagnosing causes of vertigo in general practice 2. To determine which tests should be investigated in a diagnostic accuracy study for patients with vertigo in general practice 3. To investigate the diagnostic accuracy of selected tests for patients with vertigo in general practice 4. To construct an easy-to-use diagnostic algorithm for vertigo in general practice 5. To compare the diagnostic accuracy of GP judgement with the constructed diagnostic algorithm |
| Ethics approval(s) | Approved 14/02/2023, the Medical Ethics Committee of Amsterdam UMC (Medical Ethics Review Committee Amsterdam UMC, Boelelaan 1117, 1081 HV, Amsterdam, the Netherlands; Tel: not available; Email: not available), ref: NL83111.029.22 |
| Health condition(s) or problem(s) studied | Patients with a new episode of vertigo and/or episodic vestibular syndrome in general practice |
| Intervention | First, the researchers will perform a systematic review (I) to assess the empirical evidence on diagnostic tests for patients with vertigo in general practice. The most promising tests will be studied during an international Delphi procedure (II) to determine which tests should be investigated in a diagnostic accuracy study (III). During this study, the researchers will compare each index test with its respective reference standard. They will focus on five target conditions that account for more than 95% of vertigo diagnoses in general practice: 1. benign paroxysmal positional vertigo (BPPV), 2. vestibular neuritis, 3. Meniere’s disease, 4. vestibular migraine, and 5. central causes of vertigo. As these five target conditions have a different pathophysiology and all lack a generally accepted reference standard, the researchers will use consensus diagnosis as the reference standard. Data for each patient, including history, physical examination, and additional tests as recommended by international guidelines, will be recorded on a standardized form and independently reviewed by a neurologist and otorhinolaryngologist. For each patient, the reviewers have to decide about the presence/absence of each target condition. The researchers will calculate sensitivity, specificity, predictive values, and likelihood ratios, followed by decision rules for each target condition. Subsequently, they will conduct semi-structured interviews among patients and GPs to investigate barriers and facilitators for the successful implementation of the decision rules. The results of the interviews will be used to construct a final overarching diagnostic algorithm (IV). As clinical decision rules may have a limited effect on physicians, the researchers will perform a comparison study (V) to compare the accuracy of GP judgement with the constructed diagnostic algorithm. |
| Intervention type | Other |
| Primary outcome measure | Diagnostic accuracy is measured using sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios, and diagnostic odds ratios at a single timepoint |
| Secondary outcome measures | The methodological quality of diagnostic accuracy studies, measured using the revised Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) checklist at a single timepoint |
| Overall study start date | 01/01/2021 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Calculated sample sizes per target condition BPPD: n=403; vestibular neuritis: n=110; Ménière's disease: n=189; central causes: n=960; vestibular migraine: n=? (necessary data on disease prevalence in primary care are lacking). In order to have sufficient power for all target conditions, the aim is to include 960 participants. |
| Key inclusion criteria | 1. Aged 18 years and over 2. New episode of vertigo and/or episodic vestibular syndrome (definition: see below) 3. Presentation of symptoms during (telephone) consultation or home visit Definition of vertigo: The VERDI study will adopt the nomenclature of the Bárány society, the leading international organization for clinicians and researchers involved in vestibular medicine. The Bárány society previously realized the International Classification of Vestibular Disorders (ICVD), a uniform way to describe vestibular symptoms. The VERDI study will focus on patients with vertigo (defined by the ICVD as “the sensation of self-motion when no self-motion is occurring or the sensation of distorted self-motion during an otherwise normal head movement”) and/or episodic vestibular syndrome (defined by the ICVD as “clinical syndrome of transient vertigo, dizziness, or unsteadiness lasting seconds to hours, occasionally days, and generally including features suggestive of temporary, short-lived vestibular system dysfunction”). When assessing a patient with vestibular symptoms, the Bárány society recommends focusing on timing (onset, duration, and evolution of symptom) and triggers (actions, movements, or situations that provoke the onset of symptoms. During the diagnostic accuracy study, the researchers will investigate the diagnostic value of timing, triggers, and other (individual and combinations of) items of history taking. |
| Key exclusion criteria | 1. Serious comorbid conditions that preclude participation in the VERDI study (judgement of patient’s GP) 2. Severe cognitive impairment (judgement of patient’s GP) 3. Insufficient mastery of Dutch and English language |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1081HV
Netherlands
Sponsor information
Hospital/treatment centre
Boelelaan 1118
Amsterdam
1081 HZ
Netherlands
| Phone | +31 (0)204444444 |
|---|---|
| o.maarsingh@amsterdamumc.nl | |
| Website | http://www.vumc.nl/ |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of research will be submitted for publication to peer-reviewed scientific journals. Publication will be in accordance with the basic principles of Central Committee on Research Involving Human Subjects (CCMO) statement on publication policy. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Otto R. Maarsingh (o.maarsingh@amsterdamumc.nl). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 02/04/2024 | 04/04/2024 | Yes | No |
Editorial Notes
04/04/2024: Publication reference added.
15/02/2023: Trial's existence confirmed by ZonMw.
