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A systematic review of the quality and reporting standards of longitudinal biomarker studies in dementia and recommendations . C.W.Ritchie, L.Flicker, A. Noel-Storr, R.McShane. Background. Reporting standards drive better methodology

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slide1

A systematic review of the quality and reporting standards of longitudinal biomarker studies in dementia and recommendations

C.W.Ritchie, L.Flicker, A. Noel-Storr, R.McShane

background
Background
  • Reporting standards drive better methodology
  • Claims about a diagnostic test should be based on body of data describing
    • Validation of new test against a gold standard
  • New prodromal criteria emphasise biomarker abnormality in patients with memory impairment to aid specificity to conversion.
why conversion as gold standard
Why ‘conversion’ as Gold Standard?
  • This is the critical clinical question.
  • Does my patient have Alzheimer’s disease causing their MCI?
  • Gold standards
      • Pathology in situ years before symptoms/dementia develops. Conversion to Alzheimer’s dementia verifies Alzheimer’s pathology.
      • Longitudinal – delayed verification.
slide4
General Aims:
    • To develop a series of DTA systematic reviews
    • Biomarkers (imaging and plasma/CSF proteins)
    • Neuropsychological tests
  • Specific aims of today:
    • Restricting to biomarkers:
      • To systematically review the weight of evidence: total numbers converting
      • The quality of the methodology and reporting
methods
Methods
  • Stage 1 – Sensitive MEDLINE search from 2000 to June 2011
    • 19,104 published abstracts/references
  • Stage 2 - Abstract review
    • Inclusion criteria
      • Biomarker of interest (Ab, tau, PET, or structural MRI)
      • Longitudinal design
    • Team of 9 medical students
      • ~2,250 references each
      • All students had a batch of 100 abstracts: kappa=0.62 (moderate to good)
      • Overlapping pairs of 100: kappa=0.62-0.75 (moderate to good)
results search
Results: search

MEDLINE (Ovid SP)

19104

500

Longitudinal

1032

Cross-sectional

17572

Not relevant (background/animal/review)

77

Ab

64

tau

44

PET

124

MRI

Inter-assessor agreement

Kappa: 0.62-0.7

202 references to studies for inclusion

Accounts for multiple publications from same cohort

142 primary papers

results study size 1
Results: study size (1)

8 (6%)

79 (56%)

20 (14%)

35 (25%)

results stard
Results: STARD
  • CONSORT: consolidated standards for reporting trials
  • QUORUM: quality of reporting of meta-analyses
  • MOOSE: meta-analysis of observational studies in epidemiology
  • STARD: standards for reporting of diagnostic accuracy (2003)
stard
STARD

Item 17: Appropriate Time Interval

Item 11: Blinding

item 11 blinding
Item 11: Blinding

Describe whether or not the readers of the index tests and reference standard were blind (masked) to the results of the other test and describe any other clinical information available to the readers

item 17 t ime between tests
Item 17: Time between tests

Report time interval from the index tests to the reference standard, and any treatment administered between

starddem
STARDdem

Phase 2

Phase 1

Phase 3

Discussion, collation, re-drafting

Evaluation

Delivery

Complete

starddem1
STARDdem

Phase 2

Phase 1

Phase 3

Discussion, collation, re-drafting

Evaluation

Delivery

phase 2 delphi method n 10
Phase 2: Delphi method (n=10)

Discussion and item generation

Discussion and item generation

Round 1

Round 2

Round 3

Round 4

Round 5

2 papers

Original STARD

3 papers

Methods

Original 2 papers

STARDdem

3 papers

Results

3 papers

Methods

Discussion and item generation

Discussion and item generation

Wider web-based development of consensus of extended STARD Criteria

starddem2
STARDdem

Phase 1

Phase 3

Phase 2

Evaluation

Delivery

Discussion

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