Background
Background and rationale
Standard diagnostic service and relevant quality standards
Objectives
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To characterise the diagnostic journey of people with MS in the UK and ROI, including initial/presenting symptoms, referring specialties, investigations performed, time to completion of investigations, number of neurology appointments, functional status at diagnosis.
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To identify factors associated with diagnostic delay in the UK and ROI.
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To characterise the treatments prescribed for people with MS, including the use of DMTs and time to receipt.
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To evaluate the immediate post-diagnosis MS quality of care pathways in the UK by assessing adherence to NICE Quality Statement (QS) QS 108 Statements 1, 2 and 4, as outlined, verbatim, below [32].
QS 108 guidelines
Statement 1: Adults with multiple sclerosis (MS) are given support at the time of diagnosis to understand the condition, its progression and the ways it can be managed, by the consultant neurologist making the diagnosis. |
Audit Calculation: Proportion of adults with MS who are given information about MS, its progression and the ways it can be managed by the consultant neurologist at the time of diagnosis.
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Statement 2: Adults with multiple sclerosis (MS) are offered a face-to-face follow-up appointment with a healthcare professional with expertise in MS, to take place within 6 weeks of diagnosis. |
Audit Calculation: Proportion of adults with MS who have a face-to-face follow-up appointment with a healthcare professional with expertise in MS within 6 weeks of diagnosis.
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Statement 4: Adults with multiple sclerosis (MS) who have problems with mobility or fatigue are offered support to remain physically active. |
Audit Calculation: Proportion of adults with MS who are offered support to remain physically active.
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Methods
Study design
Centre eligibility
Patient eligibility criteria
Inclusion criteria
Exclusion criteria
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We will exclude individuals with only a possible/suspected diagnosis of MS (as opposed to confirmed).
Patient identification
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1st line: Review of locally curated lists of individuals with MS, or new diagnoses.
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2nd line: Review of MS clinic appointments.
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3rd line: Review of general neurology / neurology clinic appointments.
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4th line: Review of individuals with relevant diagnostic hospital (ICD-10) or General Practice (Read Clinical Terms Version 3) code(s) (full list in Supplement S3).
Recorded variables
Baseline measures and exposures
Outcomes
Primary outcomes
Secondary outcomes
Data collection
Data validation & quality assurance
Design
Training
Centre team structure
Data completeness and consistency
Data accuracy
Information sources
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Hospital electronic records
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Neurology clinic letter(s)
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Referral letter to neurology clinic
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Formal diagnosis letter/clinical note
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Prescription record at MS DMT centre / pharmacy records
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Radiology records of request dates and scans performed
Centre details and practice
Sample size
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According to GIRFT, neurologists are based at 118 centres in NHS England, across 24 N1 (inpatient neurology & neurosurgery), 27 N2 (inpatient neurology only), and 67 N3 (neurologists are based, without inpatient neurology) centres [34].
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Assuming similar caseloads at N1, N2 and N3 centres, diagnoses at N1 and N2 centres may encompass 43% (number of N1 or N2 centres / number of N1, N2 or N3 centres, 51/118) of the total in England.
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43% of 2,475, yields an estimate of 1064 diagnoses.
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As we aim to enrol ≥ 20 centres, of the existing 51 N1/N2 centres we estimate a minimum study population (39% of 1,064 diagnoses), i.e., 415.
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If we assume similar caseloads across the estimated 20 included centres, we anticipate ~21 individuals per centre.