Condition category
Infections and Infestations
Date applied
13/09/2005
Date assigned
03/11/2005
Last edited
06/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Godfrey-Faussett

ORCID ID

Contact details

Keppel Street
London
WC1E 7HT
United Kingdom
pgf@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Giving women instructions on how to provide sputum samples will increase the yield of smear positive tuberculosis diagnoses in a chest clinic.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Condition

Tuberculosis

Intervention

Patients in the intervention arm were referred to a designated room at the TB centre where they received guidance from a female health worker who was trained by the researcher and a senior TB control officer to provide sputum submission instructions. The female health worker was not involved in recruitment or randomisation. The following points were explained in detail to patients:
1. The importance of submitting sputum rather than saliva, and a description of visual difference between the two
2. The technique that should be used to produce a good sputum specimen (‘take three deep breaths, followed by a deep cough to bring up sputum from your lungs’)
3. The necessity of filling at least one-quarter of the container (5 ml), shown by pointing out the required level on a demonstration container
4. The importance of providing one ‘spot’ specimen and returning the next day with another specimen which has been expectorated on awakening that morning

Following instructions, which lasted between 2-3 min, patients in the intervention group were directed to the laboratory to obtain sputum submission containers.

Control group: usual procedure

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure was specimen smear-positivity.

Secondary outcome measures

The secondary outcome, specimen quality, was determined by visual assessment of specimens and microscopic assessment of Ziehl-Neelsen (ZN) stained smears, using a modification of the rating system of Bartlett.
Specimens with a purulent/mucoid/blood-stained visual appearance and/or containing polymorphoneutrophils (PMNs) on microscopic inspection were designated ‘sputum’.
Specimens with a clear/watery appearance containing squamous epithelial cells, but no PMNs were designated ‘saliva’.

Overall trial start date

01/07/2005

Overall trial end date

01/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

New male and female tuberculosis (TB) suspects, who were referred by TB centre physicians for initial diagnostic sputum testing, were eligible to participate in the trial. According to the National Tuberculosis Control programme guidelines, the criteria for enrolment were:
1. History of a cough for >3 weeks and/or fever for 1 month
2. Blood in sputum
3. Night sweats
4. Weight loss
5. Loss of appetite

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2600

Participant exclusion criteria

1. Age over 75 or below 14 years
2. History of TB diagnosis or treatment
3. Intake of oral steroids in the 3 months leading up to presentation

Recruitment start date

01/07/2005

Recruitment end date

01/09/2005

Locations

Countries of recruitment

Pakistan

Trial participating centre

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

University/education

Website

http://www.lshtm.ac.uk/

Funders

Funder type

Government

Funder name

Department for International Development (DFID) (UK) - Knowledge Programme on Tuberculosis

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17560448

Publication citations

  1. Results

    Khan MS, Dar O, Sismanidis C, Shah K, Godfrey-Faussett P, Improvement of tuberculosis case detection and reduction of discrepancies between men and women by simple sputum-submission instructions: a pragmatic randomised controlled trial., Lancet, 2007, 369, 9577, 1955-1960, doi: 10.1016/S0140-6736(07)60916-7.

Additional files

Editorial Notes