A Winogrodzka

AJ Hughes

Biomarkers Definitions Working Group

C Huang

Carl E Counsell

CE Clarke

CG Goetz

Consensus report of the Working Group on

D Twelves

David E Wright

David JM McGhee

DB Calne

DG Altman

DJ Brooks

DJ Gelb

H Brown

JC Hobart

John P Zajicek

KS Taylor

LM McShane

M Roth

M Yamamoto

MF Folstein

MJ Firbank

O Rascol

Pamela L Royle

Parkinson Study Group

Paul A Thompson

RJ Temple

S Fahn

SJ Huber

V Bewick

WJ Weiner

BMC Neurology

English

PubMed

BACKGROUND: Using surrogate biomarkers for disease progression as endpoints in neuroprotective clinical trials may help differentiate symptomatic effects of potential neuroprotective agents from true disease-modifying effects. A systematic review was undertaken to determine what biomarkers for disease progression in Parkinson's disease (PD) exist.METHODS: MEDLINE and EMBASE (1950-2010) were searched using five search strategies. Abstracts were assessed to identify papers meriting review in full. Studies of participants with idiopathic PD diagnosed by formal criteria or clearly described clinical means were included. We made no restriction on age, disease duration, drug treatment, or study design. We included studies which attempted to draw associations between any tests used to investigate disease progression and any clinical measures of disease progression. The electronic search was validated by hand-searching the two journals from which most included articles came.RESULTS: 183 studies were included: 163 (89%) cross-sectional, 20 (11%) longitudinal. The electronic search strategy had a sensitivity of 71.4% (95% CI 51.1-86.0) and a specificity of 97.1% (95% CI 96.5-97.7). In longitudinal studies median follow-up was 2.0 years (IQR 1.1-3.5). Included studies were generally poor quality--cross-sectional with small numbers of participants, applying excessive inclusion/exclusion criteria, with flawed methodologies and simplistic statistical analyses.CONCLUSION: We found insufficient evidence to recommend the use of any biomarker for disease progression in PD clinical trials, which may simply reflect the poor quality of research in this area. We therefore present a provisional 'roadmap' for conducting future disease progression biomarker studies, and recommend new quality criteria by which future studies may be judged.</p

McGhee, David J. M.

Royle, Pamela L.

Thompson, Paul A.

Wright, David E.

Zajicek, John P.

Counsell, Carl E.

University of St. Andrews - Pure

A systematic review of biomarkers for disease progression in Parkinson's disease

Background:

Using surrogate biomarkers for disease progression as endpoints in neuroprotective clinical trials may help differentiate symptomatic effects of potential neuroprotective agents from true disease-modifying effects. A systematic review was undertaken to determine what biomarkers for disease progression in Parkinson’s disease (PD) exist.



Methods:

MEDLINE and EMBASE (1950–2010) were searched using five search strategies. Abstracts were assessed to identify papers meriting review in full. Studies of participants with idiopathic PD diagnosed by formal criteria or clearly described clinical means were included. We made no restriction on age, disease duration, drug treatment, or study design. We included studies which attempted to draw associations between any tests used to investigate disease progression and any clinical measures of disease progression. The electronic search was validated by hand-searching the two journals from which most included articles came.



Results:

183 studies were included: 163 (89%) cross-sectional, 20 (11%) longitudinal. The electronic search strategy had a sensitivity of 71.4% (95% CI 51.1-86.0) and a specificity of 97.1% (95% CI 96.5-97.7). In longitudinal studies median follow-up was 2.0 years (IQR 1.1-3.5). Included studies were generally poor quality - cross-sectional with small numbers of participants, applying excessive inclusion/exclusion criteria, with flawed methodologies and simplistic statistical analyses.



Conclusion:

We found insufficient evidence to recommend the use of any biomarker for disease progression in PD clinical trials, which may simply reflect the poor quality of research in this area. We therefore present a provisional ‘roadmap’ for conducting future disease progression biomarker studies, and recommend new quality criteria by which future studies may be judged

Royle, Pamela

Warwick Research Archives Portal Repository

McGhee, David J M

Royle, Pamela L

Thompson, Paul A

Wright, David E

Zajicek, John P

Counsell, Carl E

Aberdeen University Research

Springer - Publisher Connector

A systematic review of biomarkers for disease progression in Parkinson’s disease

University of St Andrews Research Portal

Background: Using surrogate biomarkers for disease progression as endpoints in neuroprotective clinical trials may help differentiate symptomatic effects of potential neuroprotective agents from true disease-modifying effects. A systematic review was undertaken to determine what biomarkers for disease progression in Parkinson's disease (PD) exist.Methods: MEDLINE and EMBASE (1950-2010) were searched using five search strategies. Abstracts were assessed to identify papers meriting review in full. Studies of participants with idiopathic PD diagnosed by formal criteria or clearly described clinical means were included. We made no restriction on age, disease duration, drug treatment, or study design. We included studies which attempted to draw associations between any tests used to investigate disease progression and any clinical measures of disease progression. The electronic search was validated by hand-searching the two journals from which most included articles came.Results: 183 studies were included: 163 (89%) cross-sectional, 20 (11%) longitudinal. The electronic search strategy had a sensitivity of 71.4% (95% CI 51.1-86.0) and a specificity of 97.1% (95% CI 96.5-97.7). In longitudinal studies median follow-up was 2.0 years (IQR 1.1-3.5). Included studies were generally poor quality - cross-sectional with small numbers of participants, applying excessive inclusion/exclusion criteria, with flawed methodologies and simplistic statistical analyses.Conclusion: We found insufficient evidence to recommend the use of any biomarker for disease progression in PD clinical trials, which may simply reflect the poor quality of research in this area. We therefore present a provisional 'roadmap' for conducting future disease progression biomarker studies, and recommend new quality criteria by which future studies may be judged.</p

McGhee, David J.M.

University of Birmingham Research Portal

McGhee, David

Lancaster E-Prints

https://aura.abdn.ac.uk/bitstream/2164/3771/1/A_systematic_review_of_biomarkers.pdf

A systematic review of biomarkers for disease progression in Parkinson's disease

Abstract

Similar works

Full text

Available Versions

University of St. Andrews - Pure

Warwick Research Archives Portal Repository

Aberdeen University Research

Springer - Publisher Connector

Springer - Publisher Connector

University of St Andrews Research Portal

University of Birmingham Research Portal

Lancaster E-Prints