[Statlist] Independent statistician required for DMC

[silvia.cicconi at swisstph.ch]

Dear all, 

We are urgently looking for an independent statistician to join the Data 
Monitoring Committee for TIMCI: Tools for Integrated Management of 
Childhood Illness. 
 
Achieving global targets for child mortality reduction in low- and 
middle-income countries (LMICs) requires significant improvements in the 
detection and management of severely ill children in primary care. 
Existing guidelines are inconsistently implemented by health workers and, 
as they are based on clinical signs, are inadequate for the detection of 
hypoxaemia, a strong predictor of mortality. 
The TIMCI project will introduce pulse oximetry, alone or embedded into an 
electronic clinical decision support algorithm (CDSA), for the management 
of children 0 – 59 months in primary care in India and Tanzania.
 
The study is expected to start recruitment in Tanzania in Q1 2022 and in 
India in Q2 2022. It is anticipated that the DMC will meet for a kick-off 
meeting in February 2022 and then after three months from the study start 
to review and evaluate interim analysis results. In addition, regular 
reviews will be conducted throughout the course of the study as will be 
described and agreed in the DMC charter. 
 
Previous experience with cluster RCTs or LMICs setting is preferred. 
Please send queries, expressions of interest and CV outlining any previous 
DMC or TSC experience you have to silvia.cicconi at swisstph.ch 

 Please see further details below.
 

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Study Design:

A pragmatic three-arm 1:1:1 parallel group, superiority, cluster 
randomised controlled trial will be conducted in India and Tanzania over a 
12-month period. Cluster unit is the facility providing primary care 
services, with randomisation to one of the following groups:
•   Pulse oximetry plus CDSA
•   Pulse oximetry with updated IMCI chart booklet (updated to incorporate 
pulse oximetry) plus pulse oximetry job aid
•   Control (routine care)

A pilot phase occurring over a 3-month period prior to the start of the 
pragmatic cluster RCT is conducted to provide key information on 
recruitment, follow-up and intervention.  Data collected from the pilot 
phase will not be included in the final study datasets. 

The assessment of the health impact of the intervention will be 
complemented by embedded mixed methods sub-studies to evaluate other key 
components and gain a deeper understanding of the implementation 
mechanisms and context. These studies include a modified service provision 
assessments (SPAs) and qualitative studies. Data from these studies will 
be triangulated in order to generate in-depth insights into 
implementation.

An interim analysis is planned to be conducted three months after the 
start of the study to assess recruitment rate, follow-up and sample size 
assumptions. The Data Monitoring Committee will review the results and 
make recommendations to the research steering committee as to whether:
·       the sample size calculation should be adjusted based on estimated 
values in the control groups;
·       the primary outcome measures should be revised due to high number 
of missing value;
·       the study should be terminated prematurely due to inability to 
achieve its objectives.

Objectives:

The overall goal of the TIMCI project is to reduce morbidity and mortality 
in sick children attending primary care facilities, while supporting the 
rational and efficient use of diagnostics and medicines by healthcare 
providers.


Outcomes:

Co-primary outcomes:
Proportion of children with a severe complication (death or secondary 
hospitalisation) by Day 7. Secondary hospitalisation occurring at any 
point greater than 24 hours after Day 0 consultation and any 
hospitalisation occurring without referral. 
Proportion of children admitted to hospital within 24 hours of the Day 0 
primary care consultation and as a result of a referral.
Secondary outcomes include:
Proportion of children with severe complication (death or secondary 
hospitalisation) by Day 28
Proportion of children cured (defined as caregiver reported recovery from 
illness) by Day 7 
Proportion of children referred by a primary care healthcare provider to a 
higher level of care (either to a hospital or to an inpatient part of a 
larger primary healthcare facility) at Day 0 consultation 
Proportion of children completing referral to a higher level of care 
within 24 hours, of all children referred at Day 0 consultation

Expected sample size:

In Tanzania, it is estimated an average cluster size of 1680 children, 
with 22 clusters per arm.
In India, it is estimated an average cluster size of 510 children, with 40 
clusters per arm.

Recruitment duration:

12 months

Study duration per participant:

28 days

Sponsor: 

PATH NGO

Funded:

UNITAID




Silvia Cicconi
Scientific Collaborator, Statistician
 
Clinical Statistics and Data Management
Department of Medicine
  
+41 61 284 93 65 
Swiss Tropical and Public Health Institute
Socinstrasse 57, 4051 Basel, Switzerland
www.swisstph.ch 

Please note the new address below from 1 January 2022: 
Kreutzstrasse 2, 4123 Allschwil 
 
 

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