when one is not enough: randomisation by community

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When One is Not Enough: Randomisation by Community. Neal Alexander. Why randomise by community or cluster Historical development of cluster-randomised trials Emphasis on infectious diseases Recent and current contributions of TEG. Outline. - PowerPoint PPT Presentation

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When One is Not Enough:Randomisation by Community

Neal Alexander

Why randomise by community or clusterHistorical development of cluster-randomised trials

Emphasis on infectious diseases

Recent and current contributions of TEG

Outline

Rationale: some interventions are difficult or impossible to allocate or assess individually

Freeman et al 2012 TMIH

Infections are ‘dependent happenings’

Pollock 1966 WHO monograph

1990 1995 2000 2005 2010

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Cluster-randomized Trials in PubMed

1990 1995 2000 2005 2010

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Cluster-randomized Trials in PubMed

Ferebee et al (1963): isoniazid prophylaxis in mental institutions

1990 1995 2000 2005 2010

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Cluster-randomized Trials in PubMedThe Gambia Hepatitis Intervention Study (1987)

1990 1995 2000 2005 2010

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Cluster-randomized Trials in PubMedBednets in Gambian villages (Snow et al 1988)

1990 1995 2000 2005 2010

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publication year

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Cluster-randomized Trials in PubMedIndirect effects (Halloran et al 1991)

1990 1995 2000 2005 2010

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publication year

tota

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Cluster-randomized Trials in PubMed

a

b

c

d

k

l

g

f

e

h

j

i

Town

Railway

Road

5. Lakeshore 4. Lakeshore

2. Islands

1. Rural villages6. Rural villages

3. Roadside

*

*

*

*

*

*

Management of STDs for HIV(Grosskurth et al 1995)

a

b

c

d

k

l

g

f

e

h

j

i

Town

Railway

Road

5. Lakeshore 4. Lakeshore

2. Islands

1. Rural villages6. Rural villages

3. Roadside

*

*

*

*

*

*

Lancet 2009

Compares: community-wide isoniazid preventive therapy vs standard of TB care

1ary endpoint: TB incidence over 12 monthsResults unveiled at CROI 2012 by Fielding & Churchyard

Hostels Mine shaft

Cluster

% a

nnua

l rai

nfal

l in

3 m

onth

s

2009

gene

freq

uenc

y0.

00.

40.

8 s=0.3s=0.2

inner scale: time in years, assuming three generations per year outer scale: generation number

logi

t(gen

e fre

quen

cy)

1 2 3 4 5 6 7 8 9 10

0 5 10 15 20 25 30

-40

24

-2

Design & Analysis of Trials to Compare Genetic Selection Coefficients

Spatial Analysis of ‘Spillover’

Anaya-Izquierdo et al in prep; trial in Kroeger et al BMJ 2002

km

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