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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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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 of longitudinal biomarker studies in dementia and recommendations

  • 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? of longitudinal biomarker studies in dementia and recommendations

  • 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.


  • General Aims: of longitudinal biomarker studies in dementia and recommendations

    • 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 of longitudinal biomarker studies in dementia and recommendations

  • 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 of longitudinal biomarker studies in dementia and recommendations

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) of longitudinal biomarker studies in dementia and recommendations

8 (6%)

79 (56%)

20 (14%)

35 (25%)


Study size 2 number converting
Study size (2): number converting of longitudinal biomarker studies in dementia and recommendations


Results stard
Results: STARD of longitudinal biomarker studies in dementia and recommendations

  • 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)


Results items fully reported
Results: items fully reported of longitudinal biomarker studies in dementia and recommendations


Stard
STARD of longitudinal biomarker studies in dementia and recommendations

Item 17: Appropriate Time Interval

Item 11: Blinding


Item 11 blinding
Item 11: Blinding of longitudinal biomarker studies in dementia and recommendations

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 11 blinding1
Item 11: Blinding of longitudinal biomarker studies in dementia and recommendations

32%

23%


Item 17 t ime between tests
Item 17: of longitudinal biomarker studies in dementia and recommendations Time between tests

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


Item 17 time between tests
Item 17: Time between tests of longitudinal biomarker studies in dementia and recommendations


Item 17 time between tests1
Item 17: Time between tests of longitudinal biomarker studies in dementia and recommendations


Starddem
STARDdem of longitudinal biomarker studies in dementia and recommendations

Phase 2

Phase 1

Phase 3

Discussion, collation, re-drafting

Evaluation

Delivery

Complete


Starddem1
STARDdem of longitudinal biomarker studies in dementia and recommendations

Phase 2

Phase 1

Phase 3

Discussion, collation, re-drafting

Evaluation

Delivery


Phase 2 delphi method n 10
Phase 2: Delphi method (n=10) of longitudinal biomarker studies in dementia and recommendations

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 of longitudinal biomarker studies in dementia and recommendations

Phase 1

Phase 3

Phase 2

Evaluation

Delivery

Discussion


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