We aim to investigate if the E-PSS is able to discriminate patients with polyneuropathy from patients without polyneuropathy in patients with diabetes and/or chronic kidney failure and determine an optimal cut-off value. Primary Objective: Is the…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the performance of the E-PSS expressed as area
under the curve (AUC) and visualize this with a receiver operating
characteristic (ROC) curve. Using the Youden*s J statistic we will determine
the cut-off value with the best discrimination performance. We will evaluate
the performance further with the sensitivity and specificity for this cut-off
value.
Secondary outcome
Secondary objectives are:
- the prevalence of polyneuropathy,
- the proportion of underdiagnosed polyneuropathy
- the prevalence of co-occurrence of risk factors
- usage of neuropathic painkillers
- the relationship between presence of polyneuropathy and severity, duration
and treatment of the underlying disease
Background summary
Polyneuropathy is often undiagnosed. It has considerable morbidity and is a
substantial burden to the health care. It is a multifactorial disease with
diabetes and kidney failure as prominent known risk factors. Early detection is
important, but diagnosing polyneuropathy is complex. The Erasmus Polyneuropathy
Symptom Score (E-PSS) is a newly developed simple six-item symptom score. It
has only been validated in a neurological outpatient clinic, but not yet in an
internal medicine outpatient setting with patients with diabetes mellitus and
kidney failure.
Study objective
We aim to investigate if the E-PSS is able to discriminate patients with
polyneuropathy from patients without polyneuropathy in patients with diabetes
and/or chronic kidney failure and determine an optimal cut-off value.
Primary Objective:
Is the Erasmus Polyneuropathy Symptom Score (E-PSS) questionnaire able to
discriminate patients with polyneuropathy from patients without polyneuropathy
in patients with diabetes mellitus and/or chronic kidney failure and what is
the optimal cut-off value?
Secondary Objective(s):
- What is the prevalence of polyneuropathy in patients with diabetes mellitus
and/or chronic kidney failure at a non-academic internal medicine outpatient
clinic?
- How often is polyneuropathy underdiagnosed in patients with diabetes mellitus
and/or chronic kidney failure at a non-academic internal medicine outpatient
clinic?
- Is the presence of polyneuropathy related to the severity/regulation,
duration, and treatment of the underlying condition?
- What is the prevalence of co-occurrence of risk factors of polyneuropathy at
a non-academic internal medicine outpatient clinic?
- How often are neuropathic painkillers used in patients with diabetes mellitus
and/or chronic kidney failure at a non-academic internal medicine outpatient
clinic?
Study design
We will perform a cross-sectional observational study.
Study burden and risks
During a visit of 30-40 min at the Albert Schweitzer hospital participant will
fill in the E-PSS questionnaire, undergo a brief history taking, as well as a
neurological examination and nerve conduction study (NCS). The NCS can be
slightly uncomfortable, but generally does not cause any pain, and is not
harmful to muscles or nerves. The risk for the participants is negligible. The
benefit for the individual participant is small, but if a polyneuropathy is
detected this can be treated following the current guidelines, whereas this
otherwise would be undiagnosed. The most important benefit will be on a group
level to improve knowledge regarding the occurrence and diagnosis of
polyneuropathy in patients with diabetes mellitus and/or chronic kidney
failure. The E-PSS is a simple and quick diagnostic tool that aims to detect
polyneuropathy and could lead to prevent under diagnosis of polyneuropathy in
patient with diabetes mellitus and/or chronic kidney failure.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Age > 18 year and diagnosed with diagnosed with diabetes mellitus type 2 or
type 1 for more than 10 year (fasting glucose >= 7.0 mmol/l or non-fasting
glucose >= 11.0 mmol/l or use of any antidiabetics) and/or chronic kidney
failure (eGFR < 30 ml/min/1.73m2)
Exclusion criteria
unable to fill in the symptom questionnaire (e.g. a language barrier or severe
cognitive problems)
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84325.078.24 |