Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis?
Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis?
This randomised controlled trial tests whether screening people registering with general
 practices cost-effectively increases the detection of tuberculosis. The study objectives are
 to:

 1. recruit, and randomise with stratification, forty Hackney general practices to usual
 activity or screening for TB primarily during registration health checks (by practice
 nurses and GPs) and transfer-in visits for children (by health visitors)

 2. implement a screening programme comprising education, resources and clinical support for
 intervention practices using proven behaviour change strategies

 3. gather outcomes and costs

 4. build research capacity within an ELENoR Primary Care Research Team and across a Primary
 Care Trust.

 The primary outcome is the proportion of TB cases identified in primary care. The study is
 powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in
 primary care with 80% power at the 5% significance level. Secondary outcomes are rates of
 prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and
 costs. Analyses will be by intention to treat.
To date, studies of screening for tuberculosis have used relatively weak designs. A
 randomised trial would give stronger evidence as to whether screening is worthwhile and
 therefore would be welcome. We have tested the feasibility of screening in two general
 practices in Hackney; our results suggest that it is simple and straightforward, that the
 people screened were comfortable taking part, and that screening does indeed identify people
 with tuberculosis.

 How (or indeed whether) to screen for tuberculosis constitutes a major policy issue for inner
 city public health care. Our work will go some way toward answering this important question
 and will have local, national and international relevance. There are important benefits for
 those taking part. First, the project is part of a local health development scheme which
 encourages GPs to register refugees and asylum seekers. This means that a group of people who
 find it difficult to get health care will be more likely to be able to find a GP. Second,
 people registering with general practices who are screening will all have a brief discussion
 about tuberculosis when they attend a health check at the surgery. This will make people more
 informed about tuberculosis and help to remove the stigma that attends tuberculosis. Third,
 screening is likely to identify people with tuberculosis, or who need BCG vaccination to
 prevent tuberculosis. These people will benefit from early treatment or immunisation.

 We will invite all general practices in Hackney to take part. Practices that agree will then
 be randomly allocated (by a computer programme) into two groups: practices who will screen
 and those who will carry on as usual without screening. The project researcher responsible
 for data collection will not know to which group the practices have been assigned. Practices
 allocated to the screening group will be offered a programme designed to encourage screening
 as part of the new patient registration checks (by practice nurses and GPs) and during
 children's transfer-in visits (by health visitors). The programme is founded on proven ways
 of helping people change how they work and includes the following: an education programme run
 by the primary care research team, with a local chest consultant as opinion leader; Heaf
 guns, Heaf heads, and tuberculin (to test for presence of TB); TB screening guidelines;
 regular support and advice from the local TB specialist nurse; incorporation of a TB
 screening template into the practice computer consulting system; and an incentive fee paid to
 the practices for carrying out the Heaf tests. TB identication rates for both groups will be
 ascertained after 25 months of screening. The cost of implementing the screening process will
 also be measured.

 Patients / public involvment (subjects and partners):

 People attending for new registration checks and children seen at transfer-in visits are the
 study participants. They will be informed about the study (using information sheets in
 various languages); they can decline to take part if they like. Public involvement in the
 design and execution of the study comes in three forms. First, the East London Refuge and
 Asylum seeker worker has contributed to the study design and will be involved throught the
 study. Second, the work is part of an East London Health Improvement Plan, which itself has
 public support. Third, the study has approval from the East London and Esssex Network of
 Researchers' Research Advisory Committee, which has two consumer representatives
Inclusion Criteria:

 The intervention is screening for TB in general practices which were randomised to control
 or intervention

 Exclusion Criteria:

 Practices that refused to participate could not be included. We excluded the general
 practice where the pilot study was undertaken