Download TB-Model-of-Care-v0 - London Health Programmes

Model of Care
TB services in London
November 2011
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List of abbreviations
The following abbreviations are used throughout this document.
A&E
Accident and Emergency
BCG
Bacille Calmette Guérin vaccine
DH
Department of Health
DOT
Directly observed therapy
ECDC
European Centre for Disease Control
GP
General Practitioner
HIV
Human Immunodeficiency Virus
HPA
Health Protection Agency
HPU
Health Protection Unit
IGRA
Interferon Gamma Release Assay
LTBR
London TB Register
LES
Locally Observed Services
MDR TB
Multi-drug resistant TB
NHS
National Health Service
NICE
National Institute of Clinical Excellence
PCT
Primary Care Trust
TB
Tuberculosis
WHO
World Health Organization
XDR TB
Extensively drug resistant TB
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Table of contents
List of abbreviations .............................................................................................................. 2
Foreword................................................................................................................................. 5
1.
Executive summary .................................................................................................. 6
2.
Conclusions from the Case for Change .................................................................. 9
3.
Patient pathway....................................................................................................... 11
4.
Improving detection and diagnosis of TB ............................................................ 12
4.1 Increasing awareness in communities at higher risk of TB ................................. 13
4.2 Improving awareness and knowledge of professionals ....................................... 14
4.3 Detecting and treating active and latent TB ........................................................ 15
5.
Improving the commissioning of TB services...................................................... 22
5.1 TB commissioning board .................................................................................... 23
5.2 Configuration of services .................................................................................... 26
5.3 Pan-London Find and Treat service .................................................................... 30
5.4 Accommodation .................................................................................................. 31
6.
Addressing variability of service provision .......................................................... 33
6.1 Establish delivery boards .................................................................................... 34
6.2 Use of risk assessment, DOT and cohort review ................................................ 36
6.3 Workforce Development Group........................................................................... 38
7.
BCG vaccination ..................................................................................................... 40
8.
Financial considerations ........................................................................................ 42
Costs......................................................................................................................... 42
Savings ..................................................................................................................... 43
9.
Success measures.................................................................................................. 44
10.
Summary of recommendations ............................................................................. 46
11.
Implementation ....................................................................................................... 47
Immediate implementation ........................................................................................ 47
Preparation for implementation in 2012/13 ............................................................... 47
Preparation for implementation 2013 and beyond .................................................... 48
Appendix A: Active and Latent TB Case Finding Protocol
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New registrants in Primary Care
Testing patients who are immunocompromised
Occupational Health Screening for new NHS employees
Appendix B: Costs of active and latent TB case finding and treatment
Appendix C: Risk assessment tool
Appendix D: Directly Observed Therapy protocol
Appendix D: TB cohort review guidance London
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Foreword
The TB Case for Change showed that the high rate of TB in London has arisen because of a
range of factors:

London’s diverse and mobile population

The variety of countries from which people in the capital originate and with which they
maintain strong links

The range of cultural values within our community

The different ways in which the disease can affect people
The different organisations involved in caring for people and the number of Londoners with
social problems have all contributed to TB’s resurgence in recent years. Such a multi-faceted
problem needs a sophisticated response.
Although Londoners generally receive high quality care once they know they have TB, more
needs to be done to identify those at risk of developing the disease, to diagnose it early, to
ensure the care given is of the highest possible standard across the capital and to ensure
treatment is completed once started. Only by addressing each of these problems will we
reverse the recent trend of rising TB rates.
This Model of Care has been developed by London’s TB community – those responsible for
providing care and treatment, for improving and protecting the health of Londoners and those
who have experienced the disease personally. It proposes changes to the way TB services
are commissioned – to ensure all the relevant agencies are engaged – and the way they are
provided – to ensure organisations work together to deliver best practice. Some of the
proposals will cost money and, although this investment will be recouped as the TB rate
begins to fall, we do not underestimate the challenge of seeking additional resources during a
time of financial constraint across the public sector.
The cost of each recommendation has been calculated with an explanation of how the figures
have been reached and, where relevant, what resources currently in the system might be
redeployed. The anticipated benefits of each recommendation are described and, where
possible, quantified. We are confident the combined effect of the recommendations will
achieve our aim of halving the TB rate over ten years.
We would like to thank the many individuals and organisations that helped us develop this
Model of Care and the Case for Change that preceded it. The members of the Clinical
Working Group and TB commissioning board are shown at the end of the document. Details
of the many other health and social care professionals, service users and third sector
partners who contributed can be found at www.londonhp.nhs.uk/tuberculosis.
Nick Relph
Chief Executive
Outer NW London Cluster
and
Senior Responsible Officer
London TB Project
Dr William Lynn
Consultant in Infectious Diseases
Ealing Hospital NHS Trust
and
Clinical Lead
London TB Project
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1.
Executive summary
This Model of Care sets out the actions required to reverse the recent trend of rising TB rates
across London. The model has been developed with London’s TB community and addresses
the issues presented in the Case for Change that preceded it. Its recommendations are
targeted at three aspects of current practice:

Early detection and diagnosis of the disease

The way services are commissioned and variability in the way services are provided.

The quality of care improves for patients and value for money is achieved.
Only by addressing all three will TB rates reduce
Improving detection and diagnosis
The Model of Care aims to improve the early detection and diagnosis of TB in London by
helping people to understand their risk of developing the disease, improving their ability to
spot early symptoms and letting them know how to seek help. It recommends a proactive
programme of awareness-raising among communities known to experience higher rates of
the disease, including those with close links to the Indian sub-continent and sub-Saharan
Africa, people with HIV/AIDS and people with certain social problems.
In addition, programmes to raise awareness of TB among health and social care workers will
be critical to ensure that earlier presentation results in prompt referral to the appropriate
service and early diagnosis.
Detecting and treating active TB to the highest possible standards will not, on its own,
achieve the goal of halving TB cases. 80% of active TB disease in London is caused by the
reactivation of latent TB infection which has been acquired earlier in life and often outside of
the UK. Currently there is no systematic, London-wide process in place to identify those with
latent infection and offer prophylactic treatment. The model proposes a targeted active and
latent TB case finding protocol aimed at new registrants in Primary Care who have recently
arrived in London from high incidence countries, new healthcare workers and those with
health problems associated with a poor immune response. We believe that targeted
intervention in these groups will substantially reduce rates of TB in London
This programme will require additional investment of £1,067,000 per year. Without it, TB
rates will continue to rise and several thousand people each year will require restrictive, often
unpleasant and sometimes very costly treatment that could be avoided. There will also be
additional treatment costs in the first few years of the programme although these will be
recouped over time as the rate of TB in the capital, and the number of people with active
disease falls.
Improving commissioning
The model proposes that a pan-London commissioning board is developed to address the
current system fragmentation by coordinating provision and strengthening the performance
management of services. The commissioning board would bring together the functions of
health care commissioning, health protection and public health to co-ordinate TB control
across the capital.
The board should, in time, take on responsibility for commissioning all specialist TB services,
although further work is required to determine how it would operate following the current
reorganisation of NHS organisations. It should continue to commission the Find and Treat
service, which works with hard to reach groups across London to identify undiagnosed cases
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of active TB and support those who have not completed treatment to re-engage with
services. More robust performance management of this service is proposed to ensure its
activities are aligned with the rest of the Model of Care.
In addition, the board would hold a central budget on behalf of commissioners which should
be used to fund temporary accommodation, managed according to strictly agreed criteria, for
a limited number of TB patients, who have no recourse to public funds but whom the NHS is
required to treat.
The treatment of clinically complex TB should be managed by clinical teams with an
appropriate level of expertise and access to specialist facilities. Three levels of service
provision are proposed, ranging from:

Level 1 - Generic primary and community care

Level 2 - Recognised TB services

Level 3 - Very specialist services
Although it is not envisaged that every patient with clinically complex TB will need to be
treated at a level 3 centre, there is a requirement that the care of these patients is managed
by a multidisciplinary team that includes clinical input from a level 3 service and that their
care is transferred should a clinical need be identified that cannot be met at the level 2
centre. This will ensure high quality TB care is delivered irrespective of where a patient lives
in London.
Addressing variability of service provision
The model proposes that five delivery boards are established across London to act as the
single provider of specialist TB services in each sector (North West London, North Central
London, North East London, South East London and South West London). These sectors
mirror the current TB networks, where strong clinical relationships are already in place and
referral patterns are well developed. Each delivery board will be led by a lead provider and
governed by an establishment agreement and local accountability arrangements. Quality of
care will be assured through a cohort review process which will be a requirement for the
provision of level 2 and level 3 services.
The delivery boards will be responsible for ensuring London protocols for the assessment of
risk, the use of DOT and cohort review are implemented and the outcome indicators specified
by the commissioning board are achieved. As a result, TB services would be delivered
consistently across the capital so all Londoners receive the same high quality care and have
equal access to services.
To ensure that the services provided by the delivery boards include an appropriate skill mix, a
workforce development group is proposed to review the capacity and capability of the current
clinical teams, identify opportunities for joint working with other agencies, ensure best value
is achieved from the available specialist expertise available and contribute to education and
training needs planning.
BCG vaccination
This document describes some of the feedback received during an engagement
period in Spring 2011 and the strength of views expressed both in favour of and
against changing London’s current approach to BCG vaccination. It proposes
Commissioners are more proactive in performance managing the current uptake of
neonatal BCG ensuring that London boroughs with TB rates ≥ 40 per 100,000
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population achieve the minimum standard of 70% coverage by the age of 12 months.
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2.
Conclusions from the Case for Change
The extent of TB in London

London as a whole has very high rates of TB. Over time there has been a significant
increase in rates and number of cases of TB, The rate in some boroughs is more than
twice that of the definition used by the WHO for high rates.

The majority of cases are in people born overseas, although it often takes several years
for them to become symptomatic.

London has large numbers of socially and medically complex cases of TB. This includes
those with HIV infection as well as risk factors for poor treatment completion and onward
transmission to others such as homeless, those with drug or alcohol problems, a history of
imprisonment and people with mental health issues.

The majority of cases in London are caused by the reactivation of latent TB, the
identification of which is costly and the treatment of which carries a clinical risk. Many
individuals who start treatment for this do not complete their prescribed course.
International comparisons

London has the highest rate of TB of any major city in Western Europe.

There have been some significant local initiatives in other European cities that have
contributed to a reduction in their TB rate and should inform the Model of Care for
London.

New York was in a similar position to London in the early 1990s and brought its TB rate
down through investment in services, a multi-faceted strategy and a coordinated, multiagency effort.
Policy framework

The care and treatment of TB is subject to several important pieces of guidance, although
both compliance with existing guidelines and implementation of new recommendations is
patchy across London.
Delays in detection and referral

Poorly informed and inaccurate beliefs about TB in the community are delaying early
presentation of the disease and increasing the risk of transmission.

A lack of understanding of the disease and its symptoms by healthcare professionals
often results in delayed diagnosis or misdiagnosis.

Current screening guidelines for TB are neither applied consistently across London nor
cost effective in detecting the disease.
Variability of commissioning

There is significant variation in the configuration and governance of the five TB networks
across London. The majority have few links to commissioning clusters and no
performance management role.
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
Those managing acute contracts in clusters have little knowledge of TB and, in general,
poor access to specialist expertise. As a result, the performance management of
providers fails to take account of the London TB metrics or the key features of TB control.

Although provider trust income increases as the TB rate rises, the capacity of TB services
often does not.

It is financially advantageous for the NHS to fund temporary accommodation rather than
hospital stays for a small group of TB patients. Although an ad hoc process has evolved
to facilitate this, it can be lengthy and is not subject to any systematic control.
Variability of service provision

Current staffing profiles within TB services often do not take account of local incidence,
the characteristics of the local population or the skill level required to deliver different
services.

The provision of directly observed therapy (DOT) varies, but apparently not in relation to
need.

The approach to tracing contacts of people with infectious TB varies, with no systematic
collection of performance or outcome data.

Uptake of BCG vaccination ranges from 24% to 80% in the parts of London where it
should be offered universally.
Risk of fragmentation

There is a significant risk that the separation of health protection, public health and
commissioning responsibilities could result in a fragmented approach to TB control in
London.
Financial considerations

The number of multi drug resistant cases of TB, and therefore the cost of TB treatment, in
London is increasing and is likely to continue to increase unless treatment completion
rates and early detection improve.

Much of the cost of treating TB is hidden in unattributable outpatient activity, but the total
cost is estimated at £25m a year.

Those parts of London that have invested in specialist non-medical teams have seen a
reduction in TB rates.

Improving early detection and treatment completion rates would, in turn, reduce the
number of TB cases requiring complex care and the overall cost of TB services.
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3.
Patient pathway
The actions proposed in the Model of Care are targeted at three aspects of the patient
pathway – improving detection and diagnosis, improving the commissioning of services and
improving the way services are provided. Each of these is described in detail in the following
sections.
Improving detection and
diagnosis
Person has TB symptoms
Increased awareness of TB
in high-risk communities
(section 4.1)
Person enters UK from
high-incidence country
Port Health service
screens high-risk
person and identifies
potential TB infection
Patient identified by
other service - Find &
Treat, prison health and
other clinical specialists
Person presents at GP
surgery, A&E department or
other urgent care centre
TB suspected and patient
referred to TB service
Increased awareness and
knowledge of TB among
healthcare professionals
(section 4.2)
TB screening programme to
detect active and latent TB
(section 4.3)
Named Case Manager
allocated
Diagnostic investigations
by TB service
Improving commissioning
London Commissioning
Board ensures the
proactive, robust
commissioning of services
(section 5.1)
Patient diagnosed
with TB
Contact
tracing &
screening
Medically complex TB is
commissioned from
specialist TB centres
(section 5.2)
Find and Treat support
treatment completion
(section 5.3)
Central accommodation
fund for homeless TB
patients
(section 5.4)
HPU referral
where
appropriate
Treatment
Patient followed up and
reviewed
Treatment completed
Improving services
Delivery Boards ensure a
coordinated, seamless
approach
(section 6.1)
London risk assessment,
DOT and cohort review
protocols are mandated in
NHS contracts
(section 6.2)
Workforce Development
Group reviews capacity and
capability of teams to deliver
the model of care
(section 6.3)
Patient discharged
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4.
Improving detection and diagnosis of TB
The TB Case for Change highlights the reasons TB is often detected late.

A lack of awareness, misconceptions and fear of the disease among many of the
communities most at risk of developing it.

A lack of awareness among healthcare professionals and resulting failure to consider TB
as a possible diagnosis.

No London-wide approach to detecting active and latent TB.
Objectives
To improve early presentation and, therefore, early diagnosis of TB, which will:

Reduce the opportunity for transmission of active TB and

Reduce the incidence and prevalence of clinically complex TB
Approach
A programme to raise awareness of TB among communities known to experience higher
rates of the disease, such as those with close links to the Indian sub-continent and subSaharan Africa, people with HIV/AIDS and homeless people (section 4.1).
A programme to raise awareness and increase the knowledge of TB among health and social
care workers so that they can recognise early signs and refer people with suspected TB to
the appropriate service (section 4.2).
A pan-London active and latent TB case finding protocol focusing on new registrations in
Primary Care, patients with conditions associated with a poor immune response and new
healthcare workers (section 4.3).
A pan-London protocol for the treatment of latent TB (section 4.3.1)
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4.1 Increasing awareness in communities at higher risk of TB
There are two major communication concerns regarding TB knowledge in London. Firstly,
awareness of the early signs and symptoms, the mechanism of transmission and the
availability of treatment is poor both within the general population and those communities
most at risk of developing the disease. Secondly, in many communities that are highly aware
of TB, individuals may not acknowledge that they have the disease or that they are at risk,
because of the stigma associated with it. This stigma is often exacerbated by misconceptions
and misinformation about how TB is spread and its prognosis.
The strategy for raising awareness, therefore, needs to maintain some central control of the
messages delivered while making best use of local channels of delivery.
The benefits of maintaining central control include:

Clarity, consistency and veracity of messages

Ability to work with other large organisations, such as the GLA, Public Health England,
Shelter etc.

Economies of scale for any required procurement

The ability to include TB messaging in any other pan London health initiatives when
relevant i.e. Choose Well.
The benefits of using local communication channels, individuals and organisations include:

Communicating TB messages through organisations that know their communities well and
understand the most effective communication techniques

Reaching those who are most at need quickly – local organisations are often able to
respond more quickly

Making use of non-health channels to deliver TB messages, such as culturally-focused
groups, social housing and employers.
To achieve this balance, a TB forum should be established for London comprising a range of
community representatives, third sector organisations and local authorities. The forum should
be a sub-group of the London TB commissioning board (see section 5.1) and should be
tasked with specifying the key messages for dissemination and advising on modes of
delivery.
There are already existing practical examples of such forums; the Fresh Thinking pan
London Sexual Health forum, includes representatives of the NHS, Local Authorities, GLA,
political representation and charitable and community groups. These members will promote
key messages to their audiences about sexual health messages for the Olympics. Ensuring
all messages are received in a manner that is effective for the audience but that is delivered
in a sustainable and controlled manner.
Key messages are likely to include information on the spread of the disease, signs and
symptoms, that TB is curable, how to access treatment and the importance of treatment
completion. Communications materials could be procured centrally by the London TB
Commissioning Board secretariat and made available to local public health services,
community groups and others as required.
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4.2 Improving awareness and knowledge of professionals
Healthcare professionals in direct access settings (Primary Care, urgent and emergency care
settings) need access to information, education and training about TB signs and symptoms
and risk factors to promote recognition, consideration of TB as a possible diagnosis and
referral to specialist services.
In an online survey undertaken by TB Alert and the HPA, GPs noted that their ability to
diagnose TB would be improved by raised awareness and a high index of suspicion,
computer alerts, rapid testing or better tests, and an easy access pathway/flow charts.
The primary objectives of any awareness and communications strategy for health
professionals will be to:

Increase the knowledge of the risks, signs and symptoms of TB of health professionals

Enable earlier diagnosis of TB by General Practitioners

Increase the speed that those with TB are referred though the patient care pathway

Increase the knowledge of TB rates and prevalence in London and local areas
There are a number of mechanisms that can be utilised to reach healthcare professionals
and increase their knowledge of TB; these could include:

Use of Continuing Professional Development (CPD) processes

Informative articles in relevant professional journals (e.g. Pulse GP magazine)

GP Pathfinder website

Utilisation of professional groups such as the London GP Council and medical and
nursing Royal Colleges

Communications through NHS organisations such as PCTs, consortia and Foundation
Trusts

Online clinical forums i.e. College of Emergency Medicine professional online forum/shop
floor
Some existing communications and training packages already exist and could be adapted
and included in any awareness raising strategy – they include:

www.doctors.net and www.nurses.net

Health Protection Units and Consultants in Communicable Disease Control (CCDCs) and
local TB services providing training seminars to GPs.

Practical extensions of this would include promoting TB as a subject matter to Pulse
bloggers, building the subject into existing forums and promoting to existing communities
of interest.
Possible key messages for health professionals include:

The active and latent TB case finding protocol

The symptoms of TB – the diagnostic information
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
The TB referral pathway

The current TB status in London and their particular locality

The management of TB, treatment methods and side effects – importance of completion
of treatment.
There would need to be a particular focus on raising awareness of Accident and Emergency
departments, as many patients, particularly those with social risk factors, with immigration
issues or who are newly arrived to the UK may not be registered with a GP and prefer to
attend A&E for health concerns in the first instance.
In the first instance conversations are being held with organisations already actively engaging
GPs. As such early discussions about use of continued professional development are in
place with the London Deanery to explore potential opportunities.
Costs and benefits of raising awareness of TB
Previous pan-London campaigns such as Choose Well (appropriate use of health services)
and a recent campaign to raise awareness of dentistry access spent £150,000 (gross
commuter press spend) and £212,075 (gross media spend) respectively.
A pan London targeted communication and awareness strategy would require a similar
spend, but it would avoid typical mass media such as commuter communication due to the
complexity of messages and desire to target communities with a tradition of oral
communication.
Funding is already in place to support formal education and training for healthcare
professionals.
The benefits would be realised through a reduction of cases requiring complex inpatient
treatment and a reduction in onward transmission of disease. Although the financial benefit
cannot accurately be predicted, the Case for Change showed that complex treatment costs,
on average, £15,000 more than an uncomplicated case and an individual with active TB can
infect 10-15 others in one year. The prevention of 10 complex cases, therefore, would make
a budget of £150,000 cost effective for this activity, even before the reduction in onward
transmission and associated treatment costs are taken into account.
Recommendation
Awareness-raising programmes should be developed for both communities at risk of
developing TB and healthcare professionals in primary and emergency care settings.
4.3 Detecting and treating active and latent TB
NICE guidance sets out in some detail which groups should be screened for TB, which tests
should be used and which individuals should subsequently be offered treatment. The Case
for Change shows that this guidance has not been fully implemented across London and that
current practice is not effective in detecting latent TB. A significant reduction in new cases of
TB in London can only be achieved by detecting and treating latent infection (80% of active
TB disease in London is cased by the reactivation of latent TB).
It is neither feasible nor cost effective to universally screen all Londoners for TB infection.
The administrative burden and clinical costs outweigh the benefits of universal screening
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based on the number of TB cases likely to be identified1. A significant impact on TB rates can
be achieved through a focussed case finding programme to detect cases of active and latent
TB infection in those at highest risk i.e. recent entrants from countries with high TB
prevalence.
There should be a systematic London-wide approach to identifying active and latent TB in ‘at
risk’ groups, including new entrants to the UK from high incidence countries, new healthcare
workers, those with conditions associated with a poor immune response and those with an
increased risk of TB because of social risk factors.
Recommendations for improving the detection of TB in recent entrants to the UK from high
incidence countries, people with poor immune response and new healthcare workers are
detailed below.
A protocol for active and latent TB case finding is at Appendix A.
4.3.1 Active and latent TB case finding protocol - new entrants to the UK
People born in countries where TB is more prevalent accounted for 84% of new cases of TB
in London in 2010. The majority of these cases had latent TB upon arrival in the country that
activated several years later, making Port of Entry screening ineffective.
Identifying and treating people with latent TB is critical to reducing rates of TB in London in
the future. Studies have suggested that approximately 63% of new entrants to the country
register with Primary Care2 and that detection of both latent and active TB in Primary Care
has been shown to have a better yield and be more cost effective than Port of Entry
screening3.
A study of the relative costs and benefits of active and latent TB case finding in different
health care settings shows that active and latent TB case finding in primary health care, when
targeted at high risk groups, is feasible, relatively inexpensive, increased the proportion of
active TB cases identified, and could prevent significant transmission through early diagnosis
and preventative measures.
Across London several Primary Care based active and latent TB case finding pilot studies
(Hackney4 and Hammersmith and Fulham5) have been effective in earlier detection of active
and latent TB in newly registered patients from high incidence countries at Primary Care
clinics, and demonstrate the feasibility of detecting active and latent TB in this healthcare
setting.
A similar scheme has been established in Newham with a dedicated Primary Care based
new entrant team offering assessment to detect latent and active TB. New entrants into the
UK are identified and contacted using port health information and invited to attend diagnostic
testing for latent and active TB.
1
NICE. Clinical guideline 117. Tuberculosis clinical diagnosis and management of tuberculosis, and measures
for its prevention and control. March 2011
2 Bothamley G, et al, Active case finding for tuberculosis: the port of arrival scheme compared with active case
finding in general practice and the homeless, 2001
3 G H Bothamley, J P Rowan, C J Griffiths, M Beeks, M McDonald, E Beasley, C van den Bosch, G Feder,
Active case finding for tuberculosis: the port of arrival scheme compared with active case finding in general
practice and the homeless. Thorax 2002;57. 2001
4 Griffiths C, Sturdy P, Brewin P, Bothamley G, Eldridge S, Martineau A, MacDonald M, Ramsay J, Tibrewal S,
Levi S, Zumla A, Feder G, Educational outreach to promote active case finding for tuberculosis in Primary Care:
a cluster randomised controlled trial, The Lancet, Volume 369, Issue 9572, May 2007
5 Zenner et al. Tuberculosis New Entrant Active case finding revisited: crafting a new Primary Care based
approach.
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NICE supports the use of a two step approach to diagnostic testing for active and latent TB in
Primary Care - the mantoux skin test, followed by an Interferon Gamma Release Array
(IGRA) blood test. Mantoux testing, however, is problematic for two reasons. First, staff need
to be trained in both its application and the interpretation of results. Training Primary Care
staff in every practice in London would be prohibitively expensive. Second, the mantoux test
requires patients to return 48 hours after the test is applied so the results can be read and
interpreted. The requirement for a second visit within a very fixed timeframe reduces
compliance with the test resulting in a poor rate of return and missed diagnoses.
The specificity of IGRA tests is more accurate, particularly the identification of latent TB, and
there is a reduction in the likelihood of false positives. Although the cost of the test itself is
higher than mantoux, this cost is outweighed by the higher rates of compliance, greater
accuracy and absence of additional training costs.
Based on the outcomes of the pilot studies and research findings an active and latent TB
case finding programme in Primary Care settings, using IGRA blood testing, is recommended
to reduce TB rates across London.
It is proposed that this approach is piloted in one cluster to test the logistics of implementing
such a programme, to develop standard protocols and to measure the effectiveness in
detecting active and latent TB. As North West London has the highest rates of TB, it is the
most obvious candidate for the pilot. If successful it is expected that Primary Care based
active and latent TB case finding should be rolled out across London.
A protocol (Appendix A) has been drafted to define the approach outlining how to identify
new GP registrations who are at higher risk of active or latent TB infection so they may be
offered a IGRA and, when indicated, referred for diagnosis and treatment.
Specifically, the protocol proposes that GPs in all London boroughs follow the tiered
approach to detecting active and latent TB. On registration with a GP practice, new
registrations from high-incidence countries should be identified using the initial case finding
questions described in the protocol. Patients found to have signs and symptoms of active TB
disease should be referred immediately to the TB services. The remaining patients should
be offered an IGRA (blood) test, and referred to specialist TB services for diagnosis and
treatment if their results indicate that they may have latent or active TB infection.
Although NICE recommends that new entrants from countries with more than 40 TB cases
per 100,000 per should be screened, recent research6 suggests this may not be the most
cost-effective approach. This study (the only comprehensive, multi-centre cost-effectiveness
analysis of new entrant active and latent TB case finding for TB in the UK and carried out in a
variety of healthcare settings) demonstrates the benefit of a more focused approach.
Although it shows the option that is most cost-effective is to detect new entrants aged 35 and
under from countries with a TB rate greater than 250 per 100,000 population, it also indicates
that this approach would fail to identify a large proportion of latent TB cases. Active and latent
TB case finding new entrants aged 35 and under from countries with a TB rate greater than
150 per 100,000 was only slightly less cost-effective7 but identified over 90% of latent TB
cases.
6
M Pareek et al. Active case finding of immigrants in the UK for imported latent tuberculosis: a multi-centre
cohort study and cost effectiveness analysis, Lancet Infectious Diseases, June 2011
7 Incremental cost-effectiveness ratios are £20,818 for 150/100,000 and £17,956 for 250/100,000 (higher ICER
indicates lower cost-effectiveness).
17
It is essential that as high a proportion of latent TB cases as possible are identified, as earlier
studies have suggested that only 63% of new entrants register with Primary Care8. New GP
registrant case finding should, therefore, focus on those arriving in London from countries
with TB rates greater than 150 per 100,000 population.
The protocol also reminds practice staff of the common symptoms of active TB that may
indicate a possible diagnosis, as well as the lifestyle and social factors that may place
patients at higher risk (for example, a history of homelessness or any condition causing
patients to become immunocompromised).
The proposal to use IGRA testing on such a wide scale presents some logistical challenges.
For example, given the requirement to analyse the sample within a tight timeframe, it may not
be possible to use some existing specimen transport facilities. Access to appropriate
laboratory time will also need to be negotiated. In addition, there are different options for
managing the ongoing prophylactic treatment of people identified with latent TB infection (see
section 4.3.4), which will require careful negotiation, monitoring and evaluation before
standard protocols can be developed.
The NWL pilot will also provide an opportunity to identify more efficient methods of delivering
the protocol and evaluate uptake. The greatest cost is treating those identified with latent TB
(see below) and it may, for example, be possible to reduce the number of outpatient
appointments required or for the monitoring of ongoing prophylactic treatment to be managed
in Primary Care. Such arrangements would require local negotiation and testing.
4.3.2 Testing patients who are immunocompromised
Immunocompromised patients should be tested for active and latent TB to ensure they
receive appropriate care and treatment and avoid complications associated with the
presence of the infection.
For the purposes of the protocol, patients who are immunocompromised include, but are not
limited to, those with AIDS/HIV infection, haematological or solid cancers, chronic kidney
disease, or treatment with immunosuppressive drugs.
In accordance with NICE clinical guidelines, the protocol sets out the circumstances and
methods by which HIV positive and other immune-suppressed patients should be tested for
TB. Where the results indicate that a patient may have TB, they should be referred to
specialist TB services for treatment. The decision whether to treat latent TB infection should
be made by the TB service, in conjunction with the patient and other clinical teams involved
in the patient’s care.
4.3.3 Occupational health screening for new NHS employees
New NHS employees (including agency and locum staff, clinical students and contract
workers) should be screened for TB. The purpose is to identify active and latent TB cases to
minimise harm to employees, the patients under their care and the general public.
This protocol includes the detailed requirements set out in NICE clinical guidelines to ensure
NHS occupational health departments adopt a standard approach to employee TB screening
across London and are monitored as part of occupational health service contracts.
8
Bothamley G, et al, Active case finding for tuberculosis: the port of arrival scheme compared with active case
finding in general practice and the homeless, 2001
18
Cost and benefits of a case finding programme
The costs of the case finding programme comprise three elements:

The cost of the tests themselves

The cost of administering the tests

The cost of treating those identified with latent or active TB.
The main determinant of costs is the size of the population to be tested. This has been
calculated using various population and Primary Care data sets (detailed in Appendix B) and
suggests approximately 44,500 would be offered an IGRA test each year, the cost of which
would be £890,000.
A LES, or equivalent payment in the region of £20 per case found (although this would
require negotiation with GP practices) is considered realistic and comparable to other similar
programmes. The fee was determined by reviewing a number of existing LES payments.
The Hackney locally enhanced service (LES) paid practices £55 for every confirmed case of
latent TB they referred. Similar pilots in Hammersmith and Fulham and Westminster,
however, did not provide additional payments. Other similar LESs include Brighton and Hove,
where GP practices receive £21 for every new entrant from a high risk country screened for
TB through a series of clinical checks; Leeds PCT pays GPs £5.52 to provide blood tests for
chemotherapy pre-assessment in cancer patients; and in West Sussex GPs are paid £18.22
(per patient) to provide and monitor repeat prescriptions for specified drugs.
If this rate were adopted, it would add £177,000 to the cost of the case finding programme.
The implementation of a case finding programme will initially result in costs for treating those
identified with latent or active TB, however this will begin to pay for itself by year six of its
implementation, where we will see a net reduction in treatment costs.
The additional treatment costs are estimated at a maximum of £5 million per annum
assuming 20% of those tested will have a positive result and require one out-patient
appointment and three follow up appointments. In practice, Delivery Boards will be expected
to develop different approaches to prophylactic treatment, such as nurse-led clinics and
shared care with GPs, which will reduce these costs considerably.
Assuming a business as usual approach to TB, notifications are forecast to reach 4080 by
2021, equivalent to a TB rate of 47 per 100,000 population. Correspondingly treatment costs
will rise from £18.6 to £22.9 million.
In comparison the Implementation of a TB case finding programme reduces the number of
active TB cases year on year and treatment costs to £13.4 million by 2021.
Figure 1 below shows the net costs for TB care in London assuming the current approach to
TB care versus the implementation of TB case finding.
Figure 1. Total cost of TB treatment – with and without a case finding programme
19
25,000,000
20,000,000
15,000,000
2012
2013
2014
2015
TB case f inding
2016
2017
2018
2019
2020
2021
Do nothing
The cost of piloting the programme in North West London in one year would be £1.75 million,
comprising of £250,000 testing costs, £1.4 million treatment costs and £50,000 in LES or
equivalent costs.
Detail of the datasets, assumptions, costs and benefits for a pan London active and latent TB
case finding programme are set out in Appendix B.
Healthcare workers
Pre-employment checks for TB are considered routine occupational health responsibility
although there is some variation of practice regarding which tests are used in what
circumstances. As the proposed protocol aims to standardise practice in line with NICE
guidance rather than introduce a new responsibility, this element of the case finding
programme should be achievable within current resources.
Co-morbidities
As the proposed protocol aims to standardise practice in line with NICE guidance rather than
introduce a new responsibility, this element of the case finding programme should be
achievable within current resources.
The benefits of the case finding programme will include an overall reduction in London’s TB
rate, improved detection and early diagnosis, minimising the risk of complex disease and
savings in the form of treatment costs avoided.
Recommendation
The active and latent TB case finding protocol for Primary Care should piloted in NWL
London focusing on new GP registrations from countries with TB rates greater than
150 per 100,000 population.
The active and latent TB case finding protocol for people with reduced immunity and
new NHS employees should be actioned across London, as per NICE guidance.
20
4.3.4 Treatment of latent TB
A systematic active and latent TB case finding protocol will identify a greater number of
patients who have latent TB and will consequently require treatment. This treatment must be
provided in a systematic and effective way that takes into account the potential risk of toxicity,
risk of side effects, duration of treatment and consequences of incomplete treatment.
NICE guidance recommends the treatment of latent TB infection for people in the following
groups, once active TB has been excluded:

35 years or younger (because of increasing risk of hepato-toxicity with age)

Any age with HIV

Any age and a healthcare worker.
Guidance for the treatment of latent TB, based on the NICE guidelines should be developed
recommending the preferred method for treating patients with latent TB. The protocol should
include:

A requirement that treatment should be initiated by a recognised secondary care TB
service

That a risk assessment must be completed as part of the secondary care assessment to
assess the likelihood of treatment completion

The circumstances in which ongoing treatment should be monitored in Primary Care or
another non-specialist setting (e.g. if the patient is already under the care of another
specialty)

Where treatment is not monitored in secondary care, trigger points throughout the
pathway that highlight when a patient should be re-referred to a specialist TB service

A methodology for confirming and recording treatment completion
Recommendation
Clinical guidelines should be developed for the detection and treatment of latent TB in
London.
21
5.
Improving the commissioning of TB services
The Case for Change highlights significant variability in the commissioning of TB services
across London. This has a number of consequences.

There is no single body that brings together the range of agencies and has the financial
and political power to control TB in London.

There is a risk that the separation of health protection, public health and commissioning
responsibilities could result in a fragmented approach to TB control in London.

The additional cost to commissioners of high TB rates does not always result in additional
investment in services.

There is little proactive planning and performance management of provider organisations
in many parts of London.

There are opportunities to reduce costs by adopting a pan-London approach to the
provision of temporary accommodation and working more closely with local government.
Objectives
1. To ensure a coordinated, multi-agency approach to the control of TB in London.
2. To ensure robust commissioning of TB services, including sound planning and strong
performance management.
3. To improve the quality and productivity of services.
4. To ensure capacity of services is related to need.
5. To exploit opportunities for cost reduction.
Approach
1. Establish a London TB commissioning board to coordinate TB control and provide
proactive, robust commissioning of TB services (section 5.1).
2. Ensure the treatment of medically complex and multi-drug resistant TB is managed
along agreed pathways by clinical teams at specialist TB centres (section 5.2).
3. Pan-London Find and Treat service to work with local delivery boards to reduce the
number of individuals failing to complete treatment (section 5.3).
4. Establish a central fund, managed by the TB commissioning board, to provide
temporary accommodation for people with TB whose homelessness is a risk to
completing treatment (section 5.4).
22
5.1 TB commissioning board
The London TB Service Review and Health Needs Assessment argued strongly for
establishment of a London TB “Control Board” to mirror the approach of New York’s fight
against TB in the 1990s.
“The commissioning of TB services for London should be performed by a London-wide body,
such as a Board of TB Control. TB is too complex and specialised a topic, and requires wide
and consistent policies and joint action, for the commissioning of TB services to be decided
by local GP commissioning consortia9.”
A pan-London commissioning board should bring together the agencies that need to be
involved in preventing, controlling and treating TB and avoid the potential fragmentation of TB
control activities described in the Case for Change. It would ensure the functions of health
improvement, health protection and service provision are considered together rather than in
isolation in different organisations.
A small, central commissioning function would include expert knowledge of the key aspects
of TB control, allowing it to specify meaningful outcomes at a strategic level that would
contribute to a reduction in TB rates across the capital. Its focus on TB control would ensure
the performance of providers is proactively managed.
London-wide commissioning would also give sufficient scale to manage effectively the
response to TB outbreaks that cross administrative boundaries and share the financial risk of
high cost, low volume multi drug resistant and extensively drug resistant TB cases.
The existing London TB commissioning board is hosted by London Health Programmes on
behalf of London’s six NHS commissioning clusters. It acts primarily as the project board for
the development of a Case for Change and Model of Care for TB and provides oversight of
the commissioning of the pan-London Find and Treat service. The membership and terms of
reference of this board should be modified to enable it to take on the functions of a TB
Control Board and a broader commissioning remit.
The objectives of the new London TB commissioning board should be to:

Ensure all relevant agencies are engaged in the control of TB in London

Achieve a year on year reduction in the incidence of TB in London

Hold providers of TB services accountable for their performance against agreed standards
of care and control.
It would achieve these objectives by:

Commissioning all TB services in London

Developing standards in relation to clinical care, investigation and prevention

Maintaining an overview of developments in research, clinical practice, diagnostics and
treatment and recommending appropriate action
9
Public Health Action Support Team. London TB Service Review and Health Needs Assessment. September
2010 p.203
23

A robust approach to performance management

Ensuring a flexible response to the spread of disease across geographical boundaries

The direction of proactive management services (such as Find and Treat, directly
observed therapy) to areas of high need

Improving the availability and analysis of NHS information on service activity and finance

Ensuring the achievement of critical mass at specialist centres

Providing risk sharing and quality assurance of low volume, high cost treatments.
Accountability of London TB Commissioning Board
An earlier draft of this document included a recommendation that the board should be part of
the NHS Commissioning Board as the only proposed statutory body in a position to take on
this responsibility across London. As details of the national reorganisation of the NHS are
finalised, other possible accountability arrangements may emerge.
Adopting TB control as a NHS Commissioning Board function remains a possibility. It would
pave the way for similar approaches to be considered in other UK cities, where TB rates are
also high. Examples include Birmingham, where TB rates in 2009 were 88 per 100,000
population and Leicester which experienced rates of 72 per 100,000 population. Birmingham
is currently reviewing its own approach to TB control.
Alternatively, it may be possible for a commissioning support organisation within London to
host the board on behalf of clinical commissioning groups. The advantage of this option is
that it would provide access to the contracting, informatics and financial management support
that would be necessary to commission TB services. There would be a risk, however, that
individual commissioning groups might opt out of the arrangement, leaving the board with
only partial coverage of London. Partial coverage would both reduce the cost-effectiveness of
a pan-London approach and weaken TB control activities.
It would be possible for the TB Commissioning Board to take on many of the responsibilities
outlined above but for the contracting function to remain with local commissioners. This
would, however, dilute the effectiveness of a pan-London approach in a number of ways.
First, without direct control of funding streams, the board’s leverage with providers would be
compromised. While the board could set standards and performance indicators for providers,
any action to address poor performance would need to be taken by the body holding the
contract. As well as introducing an additional layer of management, this approach would
continue to place demands on local commissioners. Second, the board would have little
flexibility to divert resources to areas of high need. Third, there would be little potential to
share the financial risks of high cost treatment and local outbreaks between individual
commissioners.
Membership of London TB Commissioning Board
Membership of a London TB Commissioning Board should be drawn from:

NHS commissioning organisations – to ensure links with the commissioners on whose
behalf the board would act

Clinical Commissioning Group representatives as commissioners
24

The TB clinical community – to represent the clinical reference group and provide clinical
expertise

Health Protection Agency (HPA) – to ensure the agency is engaged in TB control and the
benefits of its activities are fully realised

Public Health England – to provide public health expertise and links to local awareness,
training and control activities

General Practitioners – as providers of Primary Care

Local authorities – to ensure opportunities for joint working are recognised and exploited
and to provide a link to local health and wellbeing boards

Office of the Mayor of London and/or Greater London Assembly – to provide coordination
of agencies where necessary and provide a link to the London Health Improvement Board

TB service users – to ensure the quality of patient experience is considered alongside
financial, performance and disease control factors

Third sector and community organisations – to ensure opportunities for joint working are
recognised and exploited.
Costs and benefits of establishing a London TB Commissioning Board
A resource equivalent to 0.2 WTE would be required for each TB sector to provide
contracting, informatics and financial management commissioning support. It is likely this
would be provided by the organisation hosting the board.
A 1.0 WTE senior manager would be required to provide leadership, coordination and
specialist expertise to other functions and 0.5 WTE administrative and secretariat support.
In the developmental stage of the commissioning and delivery boards, an additional 2.0 WTE
would be needed for implementation of the model as set out in section 11.
A small amount of non-pay would be required, including a resource to buy in clinical advice.
Estimated cost £250,000.
The immediate benefits include the capacity to implement the Model of Care, including
addressing poor performance in areas with low treatment completion rates and supporting
the establishment of local delivery boards (see section 6.1). In the medium term, the board
would ensure agreed protocols were adopted (see section 6.2) and that recommendations
from the Workforce Development Group were implemented (section 6.3), improving the
productivity of services and aligning capacity with need. Longer term, a centralised
commissioning function would allow the development of pathway tariffs or unbundling
arrangements such as those adopted in North Central London.
Recommendation
A London TB Commissioning Board should be established to commission TB services
across the capital and act as a board of TB control.
25
5.2 Configuration of services
The Model of Care recommends that the treatment of medically complex and multi-drug
resistant TB is commissioned only from specialist TB centres with appropriate specialist
facilities and clinical expertise.
To ensure that the diagnosis, treatment and management of TB patients can be delivered in
the appropriate setting three levels of service provision have been defined under the
following model.
The majority of TB services in London currently operate informally within this framework
however the pan-London definition and proposed service specifications will formalise the
current process and ensure clarity for TB services in the future.
Level 1
Level 1 services have a key role to play in reducing levels of TB, by identifying TB cases, and
supporting patients and their families through treatment. Level 1 services are based in the
community, and may be provided by the acute, community, or third sector and include prison
health services.
Although level 1 services are not responsible for the treatment of active TB, they will play an
important role in:

Case finding of active and latent TB in newly registered patients

Targeted testing and potential treatment of latent TB in newly GP registered or recently
arrived people (to UK in last five years) from high risk countries in high incidence
boroughs

Community DOT delivery (via community pharmacists, Primary Care, third sector and
community organisations)

Accessing social support services for diagnosed TB patients with social risk factors.
26
Level 2
Level 2 services are recognised TB services which diagnose and treat patients with
uncomplicated TB. Providers of level 2 services may be acute (hospital) or community
services and should be available at times and locations appropriate to the needs of the
community. The key responsibilities for level 2 services are to:

Assess new patients

Perform appropriate investigations for the diagnosis of TB (such as radiological and
microbiological investigations)

Start and maintain treatment for TB, including supporting patient and their families/carers
over this time.
Much expertise and experience of managing TB resides within units which are likely to
become level 2 centres. The Model of Care will build on that but ensure that patients at most
risk of a poor outcome can benefit from the additional expertise, facilities and resources of
the level 3 centres. By fostering a collaborative approach, care will be delivered close to
where the patient lives while variability in provision will be reduced and quality improved.
Therefore, if a patient being treated by a level 2 services develops medically complex TB,
the TB patient’s care should be managed jointly with the designated level 3 service, or
transferred to a level 3 service.
All TB services should work with and assist the HPA in cluster investigation of possible linked
cases, as well as the public health management of infectious drug resistant (including MDR
and XDR) TB cases and others who may pose a public health risk.
Level 3
Level 3 services will provide the same functions as level 2 services but, in addition, will have
the clinical expertise and specialist facilities required to manage the care of patients with
medically complex TB, defined as:

Multi-drug resistant or extensively drug resistant TB

Paediatric TB disease (active) <16 years of age

Chronic renal disease or renal transplant

Patients co-infected with HIV/TB

Spinal TB

Neurological TB.
It is not essential that the provision of the level 3 services for all of the above medically
complex TB patients is on one site but it is essential that the links to medical specialities are
present. It is essential that level 3 services provide joint management of medically complex
patients with level 2 services and/or accept transfer of these patients when required.
Specialist paediatric infectious disease services managing paediatric TB should meet the
requirements for level 3 TB services as well as those set out by the London Specialised
Commissioning Group that recommends all specialised children’s services should be
provided as part of an integrated tertiary paediatric network where level 3 paediatric services
link and support paediatric TB services in level 2..
27
Patients diagnosed as requiring inpatient treatment at a level 3 service should however be
considered for transfer back to a level 2 service closer to the patient’s home or for treatment
within the home as soon as possible.
Service Specifications
Level 1 services are not specialist TB services and the care provided to TB patients will be
within existing service specifications.
The model recommends that a standard service specification for level 2 and level 3 TB
services should be applied to TB services across London to ensure that the appropriate
treatment of medically complex and multi-resistant TB is managed by clinical teams at
specialist TB centres.
Level 2 services should:

Provide care for patients with uncomplicated TB, provide DOT and enhanced case
management, where appropriate

Perform contract tracing, investigating and treatment of contracts

Provide each patient with a named case worker or case manager

Ensure that there is a named lead clinician with overall responsibility for the diagnosis and
treatment of TB

Have an established care pathway and a designated Level 3 provider which will offer
expert advice and support as necessary (including accepting transfer of care if required) –
for medically complex patients. Liaison will include maintaining a real-time register of
cases who are medically complex and the participation in joint multi-disciplinary team
reviews

Have adequate isolation facilities for hospitalised patients with suspected or confirmed
infectious TB

Have the facilities to prescribe and dispense specialist TB drugs

To meet the needs of the community by providing access to DOT seven days per week
where needed

Have appropriate diagnostic facilities for TB – diagnostic services should be reliable, high
quality, accredited and with sufficient volume to maintain clinical governance

Provide services for patients from prisons and Immigration Removal Centres

Have facilities to transfer patients to Level 3 services when clinically indicated.
In addition to meeting the requirements for Level 2, Level 3 services should:

Manage and provide specialist care for patients with multidrug resistant TB (MDR TB) or
extensively drug resistant TB (XDR TB)

Manage and provide specialist care for children under 16 years of age with TB disease
28

Provide clinical management advice and support to level 2 services caring for other
medically complex TB patients (patients with renal impairment, spinal TB, neurological
TB, HIV/TB co-infection)

Have sufficient staff with expertise to manage an average of five multi-drug resistant TB
(MDR-TB) cases per annum which are reviewed at multi-disciplinary team meetings

Negative pressure facilities with continuous monitoring achieving at least 12 air
exchanges per hour

Have facilities to provide holistic care to patients who require lengthy periods in isolation,
including access to outside space, internet access, physical activity and consideration of
mental wellbeing (e.g. occupational therapy, psychological therapy)

Have ability to monitor drug toxicity - such as audiology for aminoglycoside toxicity

Have access to biochemical testing for drug levels in blood.
Recommendation
The treatment of medically complex TB should be commissioned only from specialist
TB centres with appropriate specialist facilities and clinical expertise.
Health protection services
There are currently four Health Protection Units (HPUs) in London, each with a named TB
Lead and the London Regional Epidemiology Unit with a TB Epidemiologist supported by
Senior Scientists. The overall functions of the HPA, including those related to TB control, are
expected to transfer to Public Health England (PHE) in 2013.
It is anticipated that the HPA and HPUs will continue to carry out the functions described in
section 7 of the Case for Change:

Provide advice and information to the general public, healthcare professionals, local and
national government

Ensure that The Health Protection (Notification) Regulations 2010 are followed

Support cluster investigation, contact tracing and the cohort review process

Work with TB services to assess Public Health risk in individual cases

Collect and analyse TB surveillance data

Engage in discharge planning for drug resistant patients

Refer patients identified by Port Health to local TB services

Provide reference laboratory services.
29
5.3 Pan-London Find and Treat service
The pan-London Find and Treat (F&T) service is a small multi-disciplinary out reach team of
health and social care specialists that aim to identify people with TB from hard to reach
groups and then support them to access services and complete TB treatment.
Approximately 12% of cases of TB in London are from hard to reach groups who are at
greater risk of developing TB due to their lifestyle. These groups include people with problem
drug or alcohol use, homeless people, former and current prisoners and people with mental
health problems. Although they make up a minority of TB cases, they have a disproportionate
impact on transmission of the disease and use of resources. These groups are less likely to
access healthcare for a diagnosis, often presenting late to medical services with a worse
disease. Hard to reach groups are also known to have low treatment completion rates as
people who fall into these categories often have disorganised lifestyles that don’t match well
to the current services provided by a 9-5 outpatient service.
The F&T service uses a mobile digital chest X-ray unit (MXU) to actively visit places with hard
to reach groups where they can immediately evaluate individuals for pulmonary TB and
provide entry into appropriate services. The F&T service also supports case workers in
tracing patients who have been lost to follow-up care along with providing training and advice
for people on how to recognise TB and access healthcare.
The MXU screens for active pulmonary TB, which is most prevalent in hard to reach groups.
A recent evaluation by the HPA10 showed that approximately 35% of all MXU cases were
asymptomatic on detection – and would not have presented for treatment without this
service.
The HPA evaluation also identified some aspects of the current service that could be
improved. Although the service covers a broad geographical area of London, some parts of
the city are under-served. A more strategic and systematic approach to planning should be
taken to ensure the service is accessible to areas, which have not made good use of it in the
past. The service should make use of local intelligence and regular updates published by the
Health Protection Agency on the epidemiology of TB across the country to plan its activities.
Some of the variability of geographical coverage is the result of variability of engagement
between F&T and local TB services. F&T should engage more effectively with TB services
across London, including where there are currently modest levels of referrals. For example,
in some areas, the team should be represented and contribute to the cohort review process.
A detailed service specification should be developed for the service and shared with local TB
services to ensure respective roles and functions are clear. F&T should also be represented
on local delivery boards to ensure it forms an integral part of each board’s provision.
Better links should be developed between F&T and the London TB Register to ensure that
F&T records are updated to include the information available within that system.
Costs and benefits
The service currently costs £816,000 per year.
The service supports an average of 250 people per year through screening for active TB, reengaging with TB treatment and supporting access to a range of health and social care
Evaluation of the Find and Treat service for the control of tuberculosis amongst hard to reach groups – Final
report. Health Protection Agency, Colindale, for the Department of Health, May 2011
30
10
services. The recent evaluation of the service by the HPA found that decommissioning it
would incur a net cost to the NHS of £1.8m - £3.2m over five years.
There is scope to make better use of this resource by developing joint initiatives with other
healthcare and public health teams wishing to target this population. In particular, HIV,
substance misuse and mental health services are keen to improve access among the same
groups. Although this would not reduce the overall cost of the service, it may allow for the
costs to be distributed more widely across specialties.
Recommendation
The commissioning board should continue to commission the Find and Treat service
but should develop a detailed service specification and robust performance indicators.
The performance of the service should be proactively managed.
5.4 Accommodation
The Case for Change highlighted the importance of stable accommodation during treatment
for TB, the poor outcomes for TB patients who are ineligible for local authority housing and
the avoidable costs to NHS commissioners of funding long inpatient stays.
Case study – Homeless TB patient
A Polish man who spoke no English was admitted through Accident and Emergency with
pulmonary TB. The patient had been living in a squat with other people from European
Union recent accession states. He was ineligible for housing because he was not
signed up to the worker registration scheme (for East European migrants). The patient
stayed on a hospital ward for four weeks, but then absconded back to his squat, where
he received directly observed therapy (in the squat) for two weeks. The squat was then
closed down by the local authority. The patient became lost to follow up, and later died.
An ad hoc process has evolved in recent years, whereby individual providers seek advice
from the London TB projects lead when housing difficulties pose a risk to treatment
completion for patients. The majority of these difficulties are resolved either through use of
the housing benefit system or in collaboration with the relevant local authority. A small
minority, however, have no recourse to public funds but pose a risk to public health that the
NHS is required to address. Under the National Health Service (Charges to Overseas
Visitors) Regulations 2011, treatment for certain specified communicable disease including
TB must be provided free of charge to all, irrespective of the patient's residency status in the
UK.
In these cases, the London TB projects lead assists in the development of a business case,
which is submitted to the relevant commissioning organisation to fund or part-fund temporary
accommodation. To date, no more than ten homeless TB patients per year have fallen into
this category.
Whilst this process is functional, it is ad hoc, informal and dependent on one individual in
terms of knowledge and capacity to respond in a timely manner. As well as creating
unnecessary delay, this approach is not systematic or governed by any agreed framework to
determine eligibility or accommodation requirements.
31
This process should be formalised to reduce the delay and mitigate the financial risk to
individual commissioners. A more coordinated approach will also give an opportunity to
engage local government at a London level to seek a contribution to these costs.
A protocol should be developed for use by local providers and the HPU to standardise the
process for requesting funding for temporary accommodation for homeless TB patients. This
should include guidance about the circumstances in which the protocol should be used, detail
of the eligibility criteria for NHS funded temporary accommodation and the process for
submission and endorsement. The protocol should be agreed in advance by NHS
commissioners to reduce delays in the approval process and the associated costs of hospital
stays. This has the advantage of allowing local teams to maintain continuity of care rather
than having a centralised facility.
The London TB Commissioning Board should manage a central budget on behalf of
commissioners with delegated authority to fund temporary accommodation in accordance
with the agreed protocol. Each cluster will pool funds to contribute to the central budget.
The TB Commissioning Board will be required to include usage of the fund in its routine
reporting, including alerting commissioners at the earliest possible stage if there is a risk of
funds being exhausted before the end of the financial year.
The introduction of a formalised protocol and centralised budget will ensure effective financial
control and a quicker process for managing homeless TB patients. The anticipated costs and
savings of the approach are outlined below and demonstrate the economic benefits of a more
robust approach.
Costs and benefits of centrally managed accommodation fund
Cost of inpatient treatment = £222 per day (minimum)
Cost of temporary accommodation = £30 - £45 per day
Estimated number of patients eligible in one year = 10
Overall financial savings to NHS = £400,000-£600,000
A proportion of this saving is currently achieved through the existing ad hoc process but this
takes six weeks or more. Formalising the process will allow for inpatient stays to be reduced
by a further four weeks per patient.
Expected further reduction of inpatient days = 280
Saving = £62,160
Savings will also accrue from ensuring treatment completion and thus reducing both
transmission of the disease and the likelihood of the development of drug resistance.
Although it is not possible to quantify this saving, the Case for Change showed that treatment
of drug resistant TB costs, on average, £15,000 more than uncomplicated TB.
It is proposed that this process is managed by the TB Commissioning Board secretariat, the
cost of which is described in section 5.1.
32
Recommendation
The London TB Commissioning Board should manage a central budget on behalf of
commissioners with delegated authority to fund temporary accommodation in
accordance with an agreed protocol.
6. Addressing variability of service provision
The Case for Change highlights significant variability the provision of TB services across
London

Compliance with NICE guidance is patchy.

Treatment completion rates vary significantly from borough to borough.

Skill mix is not always designed according to need.
Objectives
1. To ensure achievement of national standards
2. To ensure patients receive the highest quality care
3. To reduce the spread of TB through robust contract tracing
Approach
1. Develop local delivery boards to act as a single provider of services for each cluster
(section 6.1)
2. Introduce pan-London protocols for the assessment of risk, the use of DOT and cohort
review (section 6.2)
3. Establish a TB Workforce Development Group (section 6.3)
33
6.1 Establish delivery boards
The services commissioned by the London TB commissioning board should be provided via
local TB delivery boards. The delivery boards should be accountable for the provision of TB
services in defined geographical areas and act as a single provider of services to ensure
local delivery of the Model of Care, contractual and performance management arrangements.
Each delivery board should be led by a single organisation – the “lead provider” – but should
have in place an establishment agreement that sets out governance arrangements,
membership and lines of accountability. The lead provider would be the legal entity that
enters into a contract with the commissioning board and would be the accountable body for
the performance of the delivery board. The establishment agreement should state how funds
will be allocated to member organisations, the circumstances in which sanctions may be
imposed on them and what form those sanctions may take. It should also include measures
to prevent monopolistic practices by the lead provider.
The focus of the delivery boards will be:

Consistency of service provision and delivery

Flexibility of service location and hours of service provided

Integration and working with local communities

Implementation of London standards.
Each delivery board should have robust terms of reference that include frequency of
meetings, agendas and minutes, membership including non-NHS stakeholders, annual
review and how it will be represented at other relevant forums, such as the London TB
Clinical Working Group.
Delivery board membership
TB delivery boards should include providers and stakeholders representing the full range of
the model. All organisations providing TB services in the local area should be represented at
the delivery board, along with representation from active community groups, Health
Protection Units and relevant social care agencies.
Each provider represented at the board must sign up to the establishment agreement, to
ensure that there is a commitment by each member to support decisions made by the
delivery board on their behalf to implement the Model of Care.
Functions
Each board will develop an annual delivery plan setting out how it will achieve the outcomes
determined by the TB commissioning board.
The delivery plan will include:

How services will be configured in line with the levels described in section 5.2

Work with the relevant Health Protection Units i.e. surveillance, information

Education activities e.g. workshops with specific communities

Trajectories for delivery against the TB Metrics

Any planned work to develop local care standards
34

Details of resources set aside to support the board and delivery of its objectives.
Current Networks
There are currently five TB networks in London that align to the cluster arrangements with the
exception of North East London, which operates as one network. There is variability across
the networks in terms of the financial and administrative support, roles, responsibilities and
work covered. The networks are structured as a clinical/provider network or a clinical/provider
and commissioning network with management support.
The current networks provide valuable expertise in TB services and associated specialities
and are a recognisable point of reference for patients and referrers. The relationship between
the delivery boards and the current networks will be for local determination. It may be
possible for some networks to develop into delivery boards but some may wish to remain as
educational forums or act as local advisory groups to their delivery board.
There are benefits in mirroring the current boundaries that the networks operate within and
ensuring that the delivery boards align to the established geographical areas. There are
strong clinical relationships already in place, along with referral pathways to appropriate
services. The Model of Care recommends that there are five delivery boards established that
align to the current cluster arrangements that will build on the established relationships and
local services.
Cost and benefits of local delivery boards
There will be some direct costs associated with the initial establishment of the boards and the
ongoing cost of secretariat support. There will also be indirect costs to the lead provider
arising from its contract management and performance reporting responsibilities. With the
exception of setup costs, these are not new costs but are currently distributed across various
organisations. It is proposed that, as part of the implementation of this model, support is
provided by the secretariat to the TB Commissioning Board in developing establishment
agreements and performance frameworks and that recurrent costs are met from local tariff
unbundling arrangements. As each delivery board will need to develop similar internal
governance arrangements, economies of scale can be achieved by providing this support
centrally.
The Model of Care recommends that TB services are made available by a broader range of
providers within the community. The delivery boards will provide essential local co-ordination
of these services and ensure the necessary support and supervision is available for nonspecialist providers. They will also allow for local flexibility in the care pathway by ensuring
services respond to local needs and adapt to changes in epidemiology.
Recommendations
The services commissioned by the London TB commissioning board should be
provided via local TB delivery boards, each led by a lead provider.
There should be five local TB delivery boards to align geographically to the current TB
networks.
35
6.2 Use of risk assessment, DOT and cohort review
The Model of Care recommends three pan-London protocols to ensure achievement of
national standards and to improve the consistency of patient care across the capital.
6.2.1 Risk assessment
The correct assessment of a patient’s likelihood of completing treatment is essential to
ensure an appropriate package of care is developed. Patients who do not complete their
treatment are able to pass the disease on to others and are at greater risk of developing drug
resistance.
A risk assessment tool has been developed by the London TB Working Group to assess the
risk of treatment non-compliance. The tool requires that clinical teams identify and record the
risk factors that may lead to an individual’s withdrawal from treatment:

Use of illicit drugs

Homelessness or insecure tenure

History of detention in prison

Alcohol problems

Mental health issues.
Although many TB services routinely use the risk assessment tool, some do not. This tool
(see Appendix C) should be adopted as the London protocol for risk assessment and its use
mandated in NHS contracts.
6.2.2 Directly observed therapy (DOT)
DOT is an integral part of successful TB treatment as it ensures that patients take their
medication by observing and recording each dose. The London DOT protocol (see Appendix
D) recommends that DOT should be considered for TB patients with active disease whose
risk assessment indicates they have one or more risk factor of failing to complete treatment.
All TB patients should have a named case manager who is responsible for ensuring that
effective arrangements are in place for DOT.
The use of the London DOT protocol should be mandated in NHS contracts for TB services.
Although usually provided by a trained nurse or outreach worker from the local TB clinic,
there is scope to be more creative in the application of DOT to ensure that treatment is given
at a convenient time and place for the patient with TB. Delivery boards should consider
greater use of community pharmacists, GP practice staff and third sector organisations,
which are well placed to administer DOT to some patients. They should also make greater
use of a shared care model for patients with comorbidities, such as DOT provision by
workers visiting HIV patients or patients with drug or alcohol problems. Such arrangements
could be governed by local agreements that specify the supervision and training required,
communication channels and trigger points to involve the TB service.
36
Case study - North East London Community Pharmacy DOT pilot
In 2007, the North East London Sector commissioned a pilot to evaluate the efficacy of TB
services using pharmacy-based DOT. This was in response to evidence that a number of
patients requiring DOT were unable to receive it through their hospital, but would be able
to attend a local community pharmacy.
Four out of seven North East London PCTs (Barking & Dagenham, City & Hackney,
Newham and Tower Hamlets) agreed to trial the pharmacy-based DOT Model, covering
four of the five TB services in North East London.
Pharmacy-based DOT was adopted with particular success in Newham where the service
was extended beyond DOT patients to include patients treated for latent TB infection
(LTBI) and others with a higher need for supervision (e.g. those with drug resistant strains)
but for whom hospital or clinic-based DOT was inappropriate. Overall, 93% of TB and
LTBI patients successfully completed their treatment.
The pilot was evaluated in 2010 and a number of benefits were identified, including the
reduced cost of providing DOT, reduced workload for nurses, improved access and
convenience for patients and greater patient choice. The key recommendation from the
pilot was that the model should be replicated across London, in areas of medium to high
TB incidence.
6.3.3 Cohort Review
A cohort review monitors the effectiveness of case management and contact tracing and is a
retrospective exercise in which all cases on treatment for a certain time period have their
care and progress discussed. Cohort review acts as a quality assurance and audit
mechanism where TB services question and review their performance with other TB services.
An evaluation undertaken in the NCL TB Service11 showed that treatment completion rates
improved after the introduction of cohort review, alongside a reduction in the proportion of
patients still on treatment and lost to follow up after 12 months.
Contact tracing is a key priority for all cases of TB which aims:

To find associated cases

To detect latent TB infection

To identify those for whom BCG may be appropriate

To find the source of infection.
In New York, the tracing of ten contacts was recommended for each new case of TB.
Although existing literature and NICE guidance is not prescriptive regarding the specific
number of contacts to be screened in the UK, a risk assessment approach is advocated
based on the clinical features of the index case, the public health risk, and the types of
contacts. The current TB metric recommends that at least five contacts are to be screened
for every new pulmonary TB case.
11
Evaluation of the implementation of Cohort Review by North Central London TB Service, Charlotte
Anderson et al, May 2010
37
A London protocol has been developed in conjunction with the HPA that specifies how local
TB services should undertake a cohort review of every active case of TB diagnosed during a
given quarter of the year (Appendix E). Although the process has been adopted by some
services, its use is not currently routine in all TB services. Implementation of the London
cohort review protocol should be mandated in NHS contracts for TB services.
Costs and benefits of implementing standard protocols
Risk assessment and a consistent approach to DOT should be incorporated into routine
clinical practice at no additional cost. Running an effective cohort review does require the
time commitment of staff to undertake the review, however the benefits of completing the
review provide longer term gains.
There are cost savings in terms of improving treatment completion and contact investigation
outcomes although it is not yet possible to quantify these.
DOT can be resource intensive but costs can be reduced becoming more cost effective by
using other providers in the community to administer the therapy. This allows for providers
already delivering services, community pharmacists for example to administer this service at
a time often more convenient for patients. Although there would be an additional cost in
training third sector providers the overall costs would be reduced as lower banded staff
should be trained in the community to complete DOT. Due to inconsistency in service
provision and variability between sectors DOT is often delivered by staff at higher paid bands
than is necessary.
An assessment of the current TB workforce is recommended in the Model of Care that will
review third sector support and provide a baseline to establish implementing DOT in the
community.
Effective administration of DOT will also improve treatment completion rates, resulting in a
reduction in ‘lost to follow up’ patients and patients classed as ‘still on treatment’. Patients
who do not complete their treatment pose an even bigger cost to the system as they have the
potential to not only pass TB to the community but are likely to require further more costly
treatment if they develop drug resistant TB.
Recommendation
The use of London protocols for risk assessment, directly observed therapy and
cohort review should be mandated in NHS contracts for TB services.
6.3 Workforce Development Group
Staffing profiles and skill-mix in TB services across London are notably varied and do not
consistently correspond to TB service requirements and patient treatment needs. The
increase in TB numbers and associated workload has not routinely been matched by
increased capacity within the TB teams.
The London TB Service Review and Health Needs Assessment made recommendations that
each TB service should be adequately staffed with specialist nurses and administrative
support and all services should achieve the minimum standard of one specialist nurse per 40
notifications per year. These recommendations should be considered further following a
review of the functions and skills required to meet the needs of the patient pathway. This
should include the specialist skills and functions currently available in TB services, team
structure and scope to make better use of the third sector.
38
A TB Workforce Development Group should be established as a sub-group of the TB
Commissioning Board, to undertake this review. It should consider which aspects of the
Model of Care are likely to have an impact on the TB workforce, review current staffing
profiles and support services to develop workforce plans to address shortfalls. It should also
provide input to training planning and identify opportunities for joint working.
Its focus should include:

The skill set required to undertake the case management role and appropriate grading of
staff

The training and supervision requirements for other providers to deliver DOT

Identification of functions currently undertaken by staff with specialist skills that could be
managed by less specialist staff

Understanding existing training provision and future training needs, including
consideration of minimum training requirements for TB staff

The priorities for any specialist time released as a result of implementing change e.g.
contributing to training other healthcare professionals.
In 2008 an audit of training needs12 made a number of recommendations for the delivery of
an appropriate workforce to provide TB services in London. Specific recommendations
relating to staffing in TB services made by the audit should be considered alongside the remit
of the Workforce Development Group.
The group should have appropriate representation from key stakeholders to fulfil the tasks
and should be led by a workforce development specialist. The group will report to the TB
Commissioning Board regularly on progress against its defined objectives.
A TB Workforce Group was established in 2009 as a forum for health and social care
professionals working in TB services. Specifically the group seeks to ensure equity of high
quality care, identify areas for development and to act as a forum for sharing good practice. It
is feasible that this group could adapt to manage the work arising from the implementation of
the Model of Care. If so, it is recommended that the current membership and terms of
reference are reviewed.
Costs and benefits of a workforce development group
Should the existing London TB Workforce Group restructure to take on the work associated
with the Model of Care it is not anticipated that there will be any additional costs.
Restructuring teams and skill mix to create an appropriate workforce fit for purpose will result
in a more cost effective workforce. The potential transfer of DOT functions to the third sector
will create capacity in the NHS for nurses and social care staff and improve treatment
completion outcomes.
Recommendation
A workforce development group should be established to review the capacity and
capability of clinical teams to deliver the Model of Care.
12
Audit Evaluation of Pan-London TB Services and Training Needs. London South Bank University. 2008.
39
7. BCG vaccination
The national approach to BCG vaccination is a risk-based programme, targeted at infants
most at risk of exposure to TB. It should be offered to all infants in boroughs with a TB rate
higher than 40 per 100,000 population in order to target vaccination to children who may be
at increased risk of TB in an effective way. This does not imply that living in these areas puts
children at increased risk of TB infection as most infections of children are likely to occur in
household settings. In areas with a lower incidence, vaccination is offered to those whose
families come from countries where the TB incidence is 40 cases per 100,000 or greater 13.
Academic opinion regarding the effectiveness of the BCG vaccine and whether it should be
given routinely is varied. A meta-analysis of worldwide trials in 1994 showed the protective
effects of BCG from TB infection ranged from 20% to 80% and lasted up to 15 years.
Differing methodological approaches, vaccines and strains of BCG, the tuberculin status of
subjects and genetic differences in populations are given as reasons for variability.
Debate about the effectiveness of BCG has resulted in a lack of international consensus
about universal administration of the vaccine and at what age it is given. In 2002 routine
infant BCG vaccination was practiced in 157 countries, in other countries BCG is not
performed, not given to children under school age or only given to at risk groups.
There has been no recent UK-specific research into the effect of the vaccine in infancy with
results from a London-wide study of BCG in infancy expected to be published in 2012, as
well as an updated systematic review and meta-analysis. The National Institute for Health
Research has just begun a four year observational study to evaluate how long the effect of
BCG lasts (and at what level) both for vaccine given to infants and to school children.
The Joint Committee on Vaccination and Immunisation (JCVI), which advises the Department
of Health on vaccination policy, reviewed the scientific evidence for changing the current
policy in 2010 following a request from the Mayor of London. The committee concluded that
the current policy remains appropriate for London based on the available scientific evidence.
The Public Health Action Support Team noted that overall in 2008/09 London achieved only
64% neonatal BCG coverage by 12 months in boroughs which were expected to achieve
75%. This ranged from 45% to 80% and several boroughs were unable to report any
information. Its report also suggested ‘an apparent lack of action to improve coverage
rates’.14
The Case for Change showed that both uptake of neonatal BCG in London and how it is
administered varies considerably. As part of the development of this Model of Care, London
Health Programmes sought views on a proposal to consider London a single geographical
entity for the purposes of BCG. As the London-wide TB rate is greater than 40 per 100,000
population, this would have had the effect of making the vaccination available to all new born
children in London. The advantage of this suggestion is simply that a uniform BCG policy for
London is both pragmatic and easier for the public and healthcare staff to understand than a
policy which varies across different boroughs. The downside of this approach is that BCG
would be administered in some boroughs with a lower TB rate which would not be consistent
with JCVI guidance and may be an ineffective use of resources.
13
TB chapter of Immunisation against infectious disease.
http://www.dh.gov.uk/en/Publichealth/Immunisation/Greenbook/index.htm
14 Public Health Action Support Team. London TB Service Review and Health Needs Assessment. September
2010, page 16.
40
This issue prompted a substantial amount of feedback during the eight week engagement
period in spring 2011. Many people, including members of the public, politicians and some
clinicians, strongly supported universal BCG as a key measure to reduce TB rates in London.
They believed that universal provision would improve uptake and help to address variable
provision by embedding vaccination within routine post-natal care.
About an equal number of respondents were critical of the proposal. They questioned the
efficacy and cost-effectiveness of the vaccine and expressed concerns about the capacity of
services to administer it. Several felt that it would be a better use of resources to improve the
uptake of BCG in high-prevalence boroughs where it was already offered.
In view of the strength of feeling expressed during the engagement period, the questions
raised about the evidence for BCG and the differences of findings in the academic literature a
change in current BCG provision is not suggested.
However it is clear that local services must improve the uptake of neonatal BCG where it is
expected to be delivered under existing guidance. As part of this process providers will be
expected to review their current method of delivery learning from services and areas where
there is high neonatal BCG uptake.
Advice on BCG policy rests with the JCVI and it will be important for the lessons learnt from
improving uptake of BCG across London, in line with JCVI guidance, are used to inform
future discussion with JCVI on the most effective way of ensuring appropriate coverage for
the London population.
Recommendation
Commissioners to performance manage the uptake of neonatal BCG ensuring
that London boroughs with TB rates ≥ 40 per 100,000 population achieve a
minimum of 70% uptake in infants by age 4 months and 75% by 12 months
after birth.
Review of BCG vaccination policy in Boroughs with <40 per 100,000 population
to evaluate uptake in high-risk groups in line with JCVI guidance.
41
8.
Financial considerations
While it is relatively straightforward to identify specific costs associated with individual
proposals in the Model of Care, the savings each will generate are more difficult to calculate.
Although many of the recommendations will result in reduced costs – such as improving
treatment completion rates, which will, in turn, lead to a reduction in the number of MDR TB
cases – there is insufficient quantitative data available to reliably quantify that reduction. The
anticipated costs and benefits of each recommendation are discussed in the relevant
sections of this document. This section summarises the financial costs and savings to be
achieved, where they can be calculated.
Costs
Awareness raising programme
£150,000
Costs of IGRA tests for case finding programme
£890,00015
Cost of LES or equivalent for case finding programme
£177,00016
Establish London Commissioning Board
£250,000
Find and Treat
£816,000
Central accommodation budget
£100,000
Sub Total
£2,383,00017
Currently funded or potential to redeploy:
LHP project funding
£254,000
Find and Treat
£816,000
Ad hoc accommodation funding
£100,000
Sub Total
£ 1,170,000
Additional investment required
£1,213,000
The total additional investment required in year one would be £546,000 plus a maximum of
£1.4m additional treatment costs as TB case finding would be limited to NW London. The
treatment costs will show as additional activity in acute contracts across the cluster.
Figure two outlines the total recurrent investment required by each cluster. Active case
finding and subsequent treatment costs apply only from year two of the programme, following
the NW London case finding pilot.
15
Full cost not applicable until year two of programme
Full cost not applicable until year two of programme
17 Treatment costs for active and latent TB identified by the case finding programme are estimated to be a
maximum of £5 million across London in the first year the programme is fully operational. Actual costs are likely
to be lower and will reduce each year (see section 4.3 of model of care).
16
42
Figure two. Recurrent investment required by cluster
Awareness raising,
London Commissioning
Board and
Central Accommodation
Budget
(annual cost)18
North Central
London
Active
case
finding
costs
(year 2)19
Total programme
costs
Estimated additional
treatment costs
(maximum for year 2)
£85,500
£171,772
£257,272
£818,782
North East
London
£109,500
£265,058
£374,558
£1,263,444
North West
London
£121,500
£303,649
£425,149
£1,447,391
South East
London
£104,500
£195,633
£300,133
£932,518
South West
London
£79,000
£131,425
£210,425
£626,457
£500,000
£1,067,537
£1,567,537
£5,088,593
Total
Savings
The overarching aim of this Model of Care is to reduce the TB rate in London by 50% over 10
years.
Although the proposed active and latent TB case finding programme and the prophylactic
treatment of those identified with latent TB infection represents the greatest additional cost, it
will also generate some savings in the form of treatment costs avoided. It is estimated that
approximately 7.5% of people with latent TB infection will develop active TB within 10 years
of infection. The costing model (shown in Appendix B) shows the costs and benefits of the
treatment of latent TB. In North West London cost averted would accrue year on year from
approximately £122,000 in 2012 to £900,000 in 2021. These cost averted include prevention
of progress to active TB and of onward transmission of active TB to others.
This does not take into account earlier identification of active TB which adds to the treatment
costs avoided. Nor does it take into account that the majority of exceptionally complex cases
are the result of reactivated TB, largely because the disease usually manifests as extrapulmonary disease, is difficult to diagnose in the early stages and can cause long term
disability. As the cost of treatment of these cases is often several hundred thousand pounds,
the savings are likely to be higher than the model suggests..The establishment of a Central
Accommodation Fund and associated formal process for funding homeless TB patients with
no recourse to public funds will ensure that up to £700,000 of inpatient costs are saved each
year.
18
19
Apportionment on weighted capitation as per current London TB project funding
Apportionment based on TB rates in each sector
43
9.
Success measures
As the Case for Change and Model of Care have highlighted, various factors contribute both
to the current high rates and the cost of treatment. They include the proportion of people who
do not complete treatment, the proportion that are diagnosed late (each contributing to the
number of clinically complex cases) and the proportion of people whose latent TB infection
becomes active TB disease. The Model of Care aims to reduce the rate of TB in London by
50% over the next 10 years. The three outcome indicators, therefore, for which the London
TB Commissioning Board should be held to account are:

London’s TB rate to be less than 22 per 100,000 population by 2021

treatment completion rates to exceed 85% in all parts of London by 2014

at least 60% of new entrants to London from very high incidence countries are screened
for TB (and treatment offered if indicated) by 2015.
Several targets for TB were set nationally in the 2004 Chief Medical Officers Action Plan
‘Stopping tuberculosis in England’, including treatment completion rates and cases of drug
resistant TB. A set of metrics for London was subsequently developed and has been
reviewed regularly since. The metrics have been used primarily to monitor progress rather
than as performance indicators. The commissioning board will need to draw on these to set
outcome indicators for each of the delivery boards. There will, however, be a number of
measures that will be applicable to all and will give an indication of progress with this Model
of Care. While data are routinely collected to inform these indicators, the precise construction
may need to be developed further by the commissioning board.
To improve early detection and diagnosis:

The proportion of new entrants from very high incidence countries (notified to the HPUs)
that are identified at GP registration and offered IGRA.

Improve and monitor the proportion of new NHS employees screened for TB through
occupational health

The proportion of patients referred by a GP to specialist TB services that are seen within
two weeks.

The proportion of people given prophylactic treatment for latent TB that are confirmed as
completing treatment.
To address variability of service provision:

The proportion of people with active TB and one or more risk factors that are receiving
DOT.

The proportion of people being treated for active TB that are lost to follow up.

The average number of contacts traced and screened for each case of pulmonary TB.
This framework is shown graphically over the page.
44
Aims
Success Measures
Improving detection and
diagnosis
Improving commissioning of
services and disease control

Objectives


To improve early
presentation
To improve early diagnosis




To ensure a co-ordinated,
multi-agency approach to TB
control
To ensure robust
commissioning, including
sound planning and
performance management
To improve the productivity
of services
To ensure service capacity
correlates with needs
To exploit opportunities for
cost reduction
Addressing variability of
service provision



To ensure the achievement
of national standards
To ensure patients receive
the highest quality care
To reduce the spread of TB
through robust contact
tracing
Key outcome indicators
Measures

 London’s TB rate to be less than 22 per 100,000 population by 2021
 Treatment completion rates to exceed 85% in all parts of London by 2014
At least 60% of new entrants to London from very high incidence countries are screened for TB
(and treatment offered if indicated) by 2015
Performance indicators
§
§
§
The proportion of new entrants from very
high incidence countries (notified to the
HPUs) that are identified at GP registration
and offered screening
The proportion of patients referred by a GP
to specialist TB services that are seen
within two weeks
The proportion of people given prophylactic
treatment for latent TB that are confirmed
as completing treatment
Performance indicators
§
§
§
The proportion of people with active TB and
one or more risk factors that are receiving
DOT
The proportion of people being treated for
active TB that are lost to follow up
The average number of contacts traced and
screened for each case of pulmonary TB
45
10.
Summary of recommendations

Awareness-raising programmes should be developed for both communities at risk of
developing TB and healthcare professionals in primary and emergency care settings.

An active and latent TB case finding programme should be introduced across London
focusing on new registrants in Primary Care from countries with TB rates greater than 150
per 100,000 population, patients with reduced immunity because of other health
conditions and new NHS employees.

Clinical guidelines should be developed for the treatment of latent TB in London.

A London TB Commissioning Board should be established to commission TB services
across the capital and act as a board of TB control.

The treatment of medically complex TB should be commissioned only from specialist TB
centres with appropriate specialist facilities and clinical expertise.

The commissioning board should continue to commission the Find and Treat service but
should develop a detailed service specification and robust performance indicators. The
performance of the service should be proactively managed.

The London TB Commissioning Board should manage a central budget on behalf of
commissioners with delegated authority to fund temporary accommodation in accordance
with an agreed protocol.

The services commissioned by the London TB commissioning board should be provided
via local TB delivery boards, each led by a lead provider.

There should be five local TB delivery boards to align geographically to the current TB
networks.

The use of London protocols for risk assessment, directly observed therapy and cohort
review should be mandated in NHS contracts for TB services.

A workforce development group should be established to review the capacity and
capability of clinical teams to deliver the Model of Care.

Commissioners to performance manage the uptake of neonatal BCG ensuring that
London boroughs with TB rates ≥ 40 per 100,000 population achieve a minimum of 70%
uptake in infants by age 4 months and 75% by 12 months after birth.

Review of BCG vaccination policy in Boroughs with <40 per 100,000 population to
evaluate uptake in high-risk groups in line with JCVI guidance.
46
11.
Implementation
The London TB Service Review and Health Needs Assessment20 acknowledged the
challenge of improving TB control during a period of organisational change within the NHS
but concluded,
“…the need to improve control of TB in London is sufficiently pressing that action needs to be
planned now and implementation begun despite this uncertainty.” (p.189)
Immediate implementation
Implementation of some of the proposals in this Model of Care can begin immediately.
Awareness raising
Sufficient expertise and resource is already in place within the London Health Programmes
TB team to strengthen links with local community groups, develop awareness-raising
materials and begin work with local public health teams to commence these activities in the
final quarter of 2011/12.
Early discussions have already taken place with the London Deanery, professional journals
and education providers about targeted learning opportunities for clinical staff most likely to
find cases of undiagnosed TB, including Primary Care staff, A & E staff and midwives. The
development of learning materials and reservation of space in relevant publications is likely to
take about three months. This work could begin immediately, for delivery from the first
quarter of 2012/13.
Standard protocols
The proposed protocols for risk assessment, DOT and cohort review take into account
current examples of good practice and national guidance. Many services already use similar
protocols. Work could begin immediately to adopt those proposed in this Model of Care within
provider organisations.
Workforce development
A TB workforce group is already in place although its membership and terms of reference
need to be revised in order for it to fulfil the role envisaged in the Model of Care. The
workforce team at NHS London is represented on the TB Commissioning Board and has
already indicated its willingness to support this work at the earliest opportunity.
Preparation for implementation in 2012/13
Service configuration
The concept of level 2 and level 3 specialist TB services has been widely discussed within
the TB clinical community as part of the development of this Model of Care. It is not
considered a radical departure from current practice, although its formalisation is considered
necessary. The development of detailed service specifications could begin immediately for
inclusion in existing commissioners’ contracts for 2012/13.
Find and Treat service
20
Public Health Action Support Team. London TB Service Review and Health Needs Assessment. September
2010
47
Contracting arrangements have been established for this service during 2011/12. Work is
already underway to strengthen the service specification, reporting and performance
management arrangements for 2012/13.
Central accommodation fund
An ad hoc process has developed in recent years whereby a local commissioner, public
health specialist or provider seeks support from a member of the London Health Programmes
TB team to develop a business case for funding which is then considered at local level. As a
result, some elements of a formal process are already in place, such as a standard template
letter, financial analysis and informal eligibility criteria. A more formal approach to
governance arrangements and systematic process could be developed in the final quarter of
2011/12 to become fully operational from April 2012.
Active and latent TB case finding programme
A full implementation plan will be required to support the proposed Primary Care active and
latent TB case finding pilot in North West London. It will include negotiation with Primary Care
commissioners, GP practices, IGRA suppliers and microbiology providers, development of a
latent TB treatment protocol, fine tuning and dissemination of the screening protocol and
preparation to be undertaken by provider organisations as well as an implementation
timeline, monitoring arrangements and evaluation criteria. It is envisaged that a plan will be
developed in the final quarter of 2011/12, for implementation to begin in quarter 1, 2012/13.
London TB Commissioning Board
Although a commissioning board is already in place, its primary role to date has been to act
as a project board for the development of this Model of Care and the associated Case for
Change. Its membership and terms of reference reflect that and need to be revised before it
could take on the responsibilities described in section 5.1. It is proposed that a new
commissioning board is established to operate in shadow form from April 2012. Although
further work is needed before the new board could take on full commissioning responsibilities
(see below), it would provide oversight of the implementation of the recommendations in this
document, guidance to current commissioning organisations, bring together the agencies
involved in TB control and steer the preparation for the new commissioning and provider
arrangements to be implemented from 2013.
BCG in London
A requirement to actively performance manage the uptake of BCG in boroughs where
it should, in line with national policy, be offered to all neonates, could be mandated by
including it in the pan-London commissioning intentions for 2012/13. Discussions are
already underway to facilitate this.
Preparation for implementation 2013 and beyond
Some of the recommendations in this Model of Care require further clarity about the
structures and processes that will be in place beyond 2013 before they can be fully
implemented.
The London-wide roll-out of the Primary Care active and latent TB case finding programme
will need to be included in the Primary Care commissioning function due to transfer to the
NHS Commissioning Board in 2013. This gives adequate time for the learning from its initial
pilot in North West London to be incorporated.
The London TB Commissioning Board will require a host organisation and formal delegated
responsibility for commissioning TB services, neither of which can be finalised until the
48
configuration of commissioning and commissioning support organisations in the capital is
determined.
In addition, further analysis of current commissioner spend is required to ensure financial
projections and delegated budgets are accurate. This could be undertaken during the first
half of 2012/13. A more robust understanding of existing financial flows will enable work to
begin on local tariff unbundling arrangements, which will, in turn, support the establishment of
delivery boards.
The development of local delivery boards will require negotiation with existing provider
organisations, identification of lead providers in each sector, the development of
establishment agreements and accountability arrangements and agreement of priority
outcomes for each board. It is envisaged that the commissioning board secretariat will
support this work during the first half of 2012 with delivery boards operating in shadow form
in the latter half of the year, becoming fully operational from April 2013.
49
Appendix A: Active and Latent TB Case Finding Protocol
New registrants in Primary Care
Definition of new registrants
For the purposes of this protocol, the term new registrants refer to all patients who register
with a General Practitioner (GP) practice.
Definition of high-incidence country
For the purposes of this protocol, the term high-incidence country refers to a country with
more than 150 TB cases per 100,000 per year. These are shown at the end of this protocol.
Aim
The identification of new registrants who are at higher risk of active or latent TB infection, so
they may be referred for early diagnosis and treatment.
Procedure

New entrants to the UK, aged 35 or less, from high-incidence countries should be
identified at the point of registration with a GP practice. Patients who have spent 3
consecutive months or more in a high-prevalence country (or countries) within the past 5
years should also be identified.

To identify these patients, practice staff should obtain the following information as part of
the new patient registration process:
 The patient’s age
 The patient’s country of birth
 Whether the patient entered the UK within the past 5 years and, if so, the country they
entered from
 Whether the patient stayed outside the UK for 3 consecutive months or more during
the past 5 years and, if so, the country (or countries) they lived in.

Practice staff should also be aware that the following are common symptoms of TB, and
may indicate a possible diagnosis:
 Persistent cough
 Fever
 Nigh sweats
 Weight loss
 Fatigue
 Enlarged lymph nodes

Patients with a history of any of the following may also be at higher risk of TB:
 Homelessness
 Imprisonment
50
 Alcohol or drug problems
 Any condition that causes patients to become immunocompromised (see section 1.2)
High-risk patients offered a TB test

Patients who are new entrants within the last five years from high-incidence countries, or
have spent at least three consecutive months in a high-incidence country during the past
5 years and are aged 35 or below should be offered an interferon-gamma release assay
test (IGRA) blood test.

These patients should receive a brief verbal explanation about the procedure and be
provided with a leaflet which includes general information about TB, and clearly explains
the reasons for offering a TB test and the possible results in a way that allays fear.

Where high-risk patients decline to be tested, their higher risk of TB should be recorded in
their file notes. Practice staff should have an increased index of suspicion for TB should
they present with any of the common signs and symptoms.

Patients over the age of 35 should not routinely be offered an IGRA test as the risks of
prophylactic TB treatment outweigh the benefits for this age group. Those patients aged
over 35 who exhibit symptoms associated with active TB should be referred to the local
TB service.
Referral to TB services

Patients found to have signs and symptoms of active TB disease should be referred
immediately to the TB services.

Where the results of the IGRA test indicate that patients may have latent or active TB
infection, they should be referred by the GP to the TB service for diagnosis and/or
treatment where relevant.

Mechanisms should be in place to ensure patient’s questions and concerns are met. This
may include a follow up appointment with the practice nurse or GP if necessary.
51

Testing patients who are immunocompromised
Definition of patients who are immunocompromised
For the purposes of this protocol, the term patients who are immunocompromised includes
(but is not limited to) patients with the following:

AIDS/ HIV infection21

Chronic kidney disease22

Haematological or solid cancers

Treatment with immunosuppressive drugs, including TNFα inhibitors.
Aim
Detect active and latent TB in patients who are immunocompromised to ensure they receive
the appropriate care and treatment and avoid complications associated with the presence of
this infection.
Procedure

In accordance with NICE Clinical Guidelines23, specialist services that manage
immunocompromised patients should have processes in place to ensure the following
guidance is met:

All patients with HIV and CD4 counts less than 500 cells/mm3 should be offered an
interferon-gamma release assay (IGRA) test.

All patients with CD4 counts less than 200 cells/mm3 should also be offered a concurrent
Mantoux test. Patients with CD4 counts of 200-500 cells/mm3 may be offered an IGRA
test alone, or a concurrent Mantoux test.

All other patients who are immunocompromised should either be offered an IGRA test
alone or an IGRA test with a concurrent Mantoux test.

If either the IGRA or Mantoux test is positive, patients should be referred to specialist TB
services for appropriate treatment. The decision to treat latent TB infection should be
made by the TB services, in conjunction with the patient and other clinical teams involved
in the patient’s care.
21
Refer UK National Guidelines for HIV Testing 2008, British HIV Association, British Association of Sexual
Health and HIV, British Infection Society
(http://www.bhiva.org/documents/Guidelines/Testing/GlinesHIVTest08.pdf)
22 Refer Guidelines for the prevention and management of Mycobacterium tuberculosis infection and disease in
adult patients with chronic kidney disease, British Thoracic Society (http://www.brit-thoracic.org.uk)
23 NICE clinical guideline 117 – Tuberculosis. Clinical diagnosis and management of tuberculosis, and
measures for its prevention and control, March 2011, page 11-12
52
Occupational Health Screening for new NHS employees
Aim
Detect active and latent TB in new healthcare workers to ensure they receive the appropriate
care and treatment, to minimise possible harm to their health, patients under their care and
the general public.
Background
In accordance with NICE Clinical Guidelines24, employees new to the NHS, who:

Will be working with patients or clinical specimens should not commence work until a
tuberculosis screen or health check has been completed, or documentary evidence is
provided of such screening having taken place within the preceding 12 months.

Will not have patient or clinical specimen contact, should not commence work if they have
signs or symptoms of tuberculosis.
Application
This protocol applies to new NHS employees who have the potential for exposure to TB, by
reason of their clinical or other occupational activity.
Clinical students, agency and locum staff and contract ancillary workers who have contact
with patients or clinical materials should be screened for TB to the same standard as new
employees in healthcare environments. Documentary evidence of screening to this standard
should be sought from locum agencies and contractors who carry out their own screening.
NHS trusts arranging care for NHS patients in non-NHS settings should ensure that
healthcare workers who have contact with patients or clinical materials in these settings have
been screened for TB to the same standard as new employees in healthcare environments.
If no documentary evidence of prior screening is available, staff in contact with patients or
clinical material who are transferring jobs within the NHS should be screened as for new
employees.
Procedure
Health checks for employees new to the NHS who will have contact with patients or clinical
materials should include:

Assessment of personal or family history of TB

Symptom and signs enquiry, possibly by questionnaire

Documentary evidence of TB skin testing (or IGRA) and/or BCG scar check by an
occupational health professional, not relying on the applicant’s personal assessment

Mantoux result within the last 5 years, if available.
Employees who will be working with patients or clinical specimens and who are Mantoux
negative (less than 6 mm) should have an individual risk assessment for HIV infection before
BCG vaccination is given.
NICE clinical guideline 117 – Tuberculosis. Clinical diagnosis and management of tuberculosis, and
measures for its prevention and control, March 2011.
24
53
Employees new to the NHS should be offered BCG vaccination, whatever their age, if they
will have contact with patients and/or clinical specimens, are Mantoux negative (less than 6
mm) and have not been previously vaccinated.
Employees of any age who are new to the NHS and are from countries of high TB incidence,
or who have had contact with patients in settings with a high TB prevalence should have an
IGRA test. If the test is negative, the person should be offered BCG vaccination as with a
negative Mantoux result if there is a no history of BCG vaccination. If the test is positive, the
person should be referred to a specialist TB service for clinical assessment for diagnosis and
possible treatment of latent infection or active disease.
If a new employee from the UK or other low-incidence setting, without prior BCG vaccination,
has a positive Mantoux and a positive IGRA test, they should have a medical assessment
and a chest X-ray. They should be referred to a specialist TB service for consideration of TB
treatment if the chest X-ray is abnormal, or for consideration of treatment of latent TB
infection if the chest X-ray is normal.
If a prospective or current healthcare worker who is Mantoux negative (less than 6 mm)
declines BCG vaccination, the risks should be explained and the oral explanation
supplemented by written advice. If the person still declines BCG vaccination, he or she
should not work where there is a risk of exposure to TB. The employer will need to consider
each case individually, taking account of employment and health and safety obligations.
HIV
The risk of TB for a new healthcare worker who knows he or she is HIV positive at the time of
recruitment should be assessed as part of the occupational health checks.
The employer, through the occupational health department, should be aware of the settings
with increased risk of exposure to TB, and that these pose increased risks to HIV-positive
healthcare workers.
People identified for BCG vaccination through occupational health, contact tracing or new
entrant screening who are also considered to be at increased risk of being HIV positive,
should be offered HIV testing before BCG vaccination.
Healthcare workers who are found to be HIV positive during employment should have
medical and occupational assessments of TB risk, and may need to modify their work to
reduce exposure.
Prisons and remand centres
Healthcare workers providing care for prisoners and remand centre detainees should be
aware of the signs and symptoms of active TB. TB services should ensure that awareness of
these signs and symptoms is also promoted among prisoners and prison staff.
Reminders for staff
Reminders of the symptoms of TB, and the need for prompt reporting of such symptoms,
should be included with annual reminders about occupational health for staff who:

Are in regular contact with TB patients or clinical materials, or

Have worked in a high-risk clinical setting for 4 weeks or longer.
One-off reminders should be given after a TB incident on a ward.
54
Alphabetical list of countries with a tuberculosis incidence of >150 per 100,000
Afghanistan
India
Republic of Moldova
Angola
Indonesia
Romania
Azerbaijan
Rwanda
Kazakhstan
Bangladesh
Kenya
Sao Tome and Principe
Bhutan
Kiribati
Senegal
Bolivia
Korea, DPR
Sierra Leone
Botswana
Burkina Faso
Solomon Islands
Kyrgyzstan
Burundi
Cambodia
Somalia
South Africa
Lesotho
Sudan
Liberia
Suriname
Cameroon
Swaziland
Cape Verde
Madagascar
Central African Republic
Malawi
Tajikistan
Mali
Thailand
Chad
Marshall Islands
Timor-Leste
Congo
Mauritania
Togo
Cote d'Ivoire
Micronesia
Tuvalu
Congo, Democratic Republic
Mongolia
Djibouti
Montserrat
Uganda
Mozambique
United Republic of Tanzania
Myanmar
Uzbekistan
Namibia
Vietnam
Ethiopia
Gabon
Nepal
Gambia
Niger
Zambia
Ghana
Nigeria
Zimbabwe
Guinea
Guinea-Bissau
Pakistan
Papua New Guinea
Haiti
Philippines
55
Appendix B: Costs of active and latent TB case finding and treatment
The target population
To estimate the target population of new GP registrations eligible for TB case finding in Primary Care a
number of population datasets were considered. Eligibility for IGRA testing in Primary Care is
predicated on the persons age (>35 years), tuberculosis incidence of their country of origin (set at
150:100,000 incidence threshold) and the length of time they have been in the UK (5 years or less).
Population datasets considered are summarised below in Table 1, including comments on their validity
as an estimate baseline target population.
Table 1. Population datasets - migration and GP registrations
Dataset
Source
Definitions
Comments
Port Health
Entrants from
Heathrow and
Gatwick
Health
Protection
Units
Data derived from
Port Health
immigration entering
the UK at Heathrow
and Gatwick
Port Health data provides a good estimate
of the number of new entrants arriving
annually in the UK from high incidence
countries, including age, sex and
intended PCT of residence.
(2010-2011)
Data is restricted to people entering from
Heathrow and Gatwick and does not
include those already in the country
changing GPs. There is also a lack of
confidence in the accuracy of port health
data as a means of measuring migration.
Internal
migration
(NHSCR)NHSCR Interregional
migration
movements, UK
2010
Office of
National
Statistics
Three data sources
are used, the
National Health
Service Central
Register (NHSCR);
Patient Register Data
System (PRDS) and
the Higher Education
Statistics Agency
(HESA) data
Considered the best proxy measure for
identifying internal migration. Estimates
are based on the movement of NHS
doctors' patients between former Health
Authority Areas in England and Wales and
Area Health Boards in Scotland and
Northern Ireland.
Data is difficult to disaggregate by the
variables to get an accurate picture of the
target population.
1% of London
population –
based on the
proportion
screened for
active and latent
TB in Hackney
in 2010
Proportions
using GLA
Population
figures, 2010
People screened for
TB in Hackney
totalled 1% of the
local population in
2010
The Hackney TB case finding programme
included a country incidence threshold
for TB of 40:100,000, those over 35 years
and residence in the UK for any time
period.
Flag 4 GP
Registrations By
Local Authority
Patient
Register Data
Service held
by NHS
Connecting
for Health Office for
National
Statistics
(2008-2009)
Disaggregating the data by high incidence
country (150:100,000) and age (using HPU
proportions) provides a more accurate
estimate of the target population.
A Flag 4 is generated
if an individual
registers with a GP
[who was either born outside UK
registering for first
time or if their
previous address
was outside of UK].
Flag 4 data provides an indication of
migration into local authorities. However,
identifying the proportion from countries
with a high incidence of TB is
problematic.
The best eligible population estimate
reached assumes 53% of immigration to
the UK is non-EU (Migration Observatory
2011) and that 21% of these are Black
56
Asian Minority Ethnic (BAME, London
GLA 2009 population profiles). Using
BAME is not considered to be a good
proxy measure of people from countries
with a high incidence of TB.
Data disaggregation
Each dataset in Table 1 was disaggregated by the screening variables to determine the target
population eligible for active and latent TB case finding in London. No one dataset provides a full and
accurate picture of the target population. Two datasets at the upper and lower end of the range have
been selected to provide a mid range target population.
HPU data provides a good indication of numbers of new entrants annually from high incidence
countries, however does not take into account people at risk of TB who have been in the country for the
past five years registering with a GP. The Hackney model demonstrates in practice the number of
people screened in a Primary Care setting for active and latent TB but adopts a lower threshold for TB
incidence and no age limit representing an over estimate of the target population.
HPU data was disaggregated firstly by country of origin TB incidence (at 150:100,000) and then age
(≤35 years). It was then assumed that 63% would register with a GP based upon findings from
Bothamley et al’s (2001) study into TB screening in different healthcare settings 25. Applying these
variables to the population data, as shown in the table below, results in a target population of 24,600
eligible for TB case finding programme.
Table 2. HPU, Port Health Entrants by country of origin and age who register with a GP
Sector
North Central
North East
North West
South East
South West
HPU - All
new
entrants
6,144
14,536
15,409
6,800
4,607
47,496
New entrants - TB % new entrants rate countries
TB Rates
% new
40:100,000
150:100,000
entrants
incidence
incidence
under 35 (all)
5,834
95%
91%
14,237
95%
91%
15,059
100%
89%
6,599
93%
86%
4,442
78%
85%
46,171
New entrants
from high
incidence
New entrants
countries &
who register
under 35
with GP @ 63%
5,060
3,188
12,347
7,779
13,403
8,444
5,301
3,340
2,950
1,858
39,060
24,608
In 2010 the Hackney TB case finding programme screened 1% of the local population for TB in GP
settings based on a patients’ answers to a health check questionnaire. Assuming the same proportion
of people would be screened across London (1%) and factoring in a TB incidence of 150 per 100,000
and age limit of 35 years and under, as used in the HPU data, the target population is 64,300 (table 3).
25
Bothamley, G H et al. Screening for tuberculosis: the port of arrival scheme compared with screening in general practice and the
homeless, 2001.
57
Table 3. Hackney population model - 1% of population
Sector
North Central
North East
North West
South East
South West
26
Adult & Paeds
1% of
Population
population
1,287,087
12,871
1,655,242
16,552
1,894,434
18,944
1,620,760
16,208
1,371,599
13,716
Total
7,829,122
78,291
% from
countries with
TB incidenec of
Proportion
150:100,000 ≤ 35 years old
95%
91%
95%
91%
100%
89%
93%
86%
78%
85%
Eligible
population
11,127
14,310
16,860
12,963
9,094
64,353
The average of the data assumes a target population of 44,500 will be eligible for active and latent TB
case finding in London. This mid point of the range has been adopted and built into the economic
model to determine costs and benefits of introducing the programme across London.
Model assumptions
A number of assumptions have been applied to the data to determine costs and benefits of introducing
active and latent TB case finding in primary health care settings.






It is assumed that all individuals accept treatment for latent TB infection.
Latent TB will be detected in 20% of population tested. This is based on findings from IGRA based
testing in Pareek et al’s 2011 study screening immigrants for latent TB and its cost effectiveness 27.
In light of the large differences in published research, the progression rate of latent TB to active
disease, without treatment, in each annual latent population is calculated at 7.5% over 10 years (5%
over the first five years and 0.5% year on year thereafter). Research calculates the range from
anywhere between 6.7% over 40 years28 to 13% over 10 years29.
Individuals with latent TB who have progressed to active TB are modelled to have a fixed number of
contacts that results in a number of secondary active TB cases. 50% are assumed to have
infectious TB. Modelling assumed that 4 in 100 case of infectious TB (4%) infects another 10 cases
in 1 year.
The active and latent TB case finding programme will also detect cases of active TB. The
prevalence of active TB identified in the cohort assumes 0.03% of those screened will have active
TB based on findings from the Hackney TB case finding programme.
The target population that have been outside of the country for 3 months or more from a high
incidence country are assumed to be statistically small.
Costs
Costs for testing for active and latent TB and treating latent TB have been determined using the
following guidance.

The unit cost of an IGRA test is calculated to be £20.00 (NICE, 2006, provides a guide price of
£25.67). It is assumed that with economy of scale costs can be reduced with suppliers.
26
100% TB incidence rate in North West London is calculated based on port health data and the proportion of entrants from high
incidence countries entering into the area.
27 Pareek et al. Screening of immigrants in the UK for latent tuberculosis: a multi-centre cohort study and cost effectiveness analysis,
2011.
28 Marks et al. Incidence of tuberculosis among a cohort of Tuberculin-positive refugees in Australia, 2000.
29 Choudry & Omerod. The outcome of a cohort of tuberculin positive, predominantly South Asian, new entrants aged 16-35 to the UK:
Blackburn 1989-2001.
58





Locally Enhanced Service (LES) tariff of £20.00 paid to Primary Care providers for each case of
latent TB detected based upon a review of similar LES’s.
Initial outpatient appointments are costed at £242 as advised by the 2011/12 Department of Health
Commissioning Guidance respiratory medicine tariffs.
Outpatient follow up appointments are costed at £110 as advised by the 2011/12 Department of
Health Commissioning Guidance respiratory medicine tariffs.
HRG tariff for nurse led contact tracing is costed at £250, plus the cost of 3 months
chemoprophylaxis (HRG costing).
Costs exclude Market Forces Factors.
Testing for latent and active TB includes the cost of IGRA testing the target population.
Treatment of latent TB has been costed as one initial outpatient appointment and three out-patient
follow up appointments based on clinical advice for the treatment of latent TB. HRG Nurse led tariffs
have been considered as an alternative care pathway to consultant led outpatient follow-up
appointments.
Costs assume a LES payment of £20 will be paid to a GP practice for each identified case of latent TB.
The fee was determined by reviewing a number of existing LES payments. The Hackney locally
enhanced service (LES) paid practices £55 for every confirmed case of latent TB they referred. Similar
pilots in Hammersmith and Fulham and Westminster, however, did not provide additional payments.
Other LESs shows that in Brighton and Hove GP practices receive £21 for every new entrant from a
high risk country screened for TB through a series of clinical checks; Leeds PCT pays GPs £5.52 to
provide blood tests for chemotherapy pre-assessment in cancer patients; and in West Sussex GPs are
paid £18.22 (per patient) to provide and monitor repeat prescriptions for specified drugs.
The table below shows a breakdown of the costs the active and latent TB case finding programme for
London based on the mid range target population.
Table 4. Costs - active and latent TB case finding programme.
Target
population
Testing
Costs
Treatment
Cost
LES Cost
Total
44,500
£890,000
£5 m
£177,000
£6.1 m
Benefits
The benefits of the active and latent TB case finding programme are threefold and measured by:



Reduction in overall TB cases as fewer latent TB cases progress to active TB;
the prevention of onward transmission of active infectious TB; and
earlier detection and diagnosis of active disease.
Prevention of progression to active TB has been calculated assuming 7.5% of people with latent TB
annually would have progressed to active TB over a 10-year period.
Prevention of onward transmission assumes that of those who would have progressed to active TB,
without chemoprophylaxis, 4% would have passed on the disease to a further 10 people with TB.
59
Detection of active disease calculated as 0.03% of those tested for latent TB modelled on the findings
from the Hackney TB screening programme.
Applying these assumptions to the target population the table below shows year on year the number of
cases prevented through treatment of latent TB, prevention of onward transmission and detection of
active disease for the target population. The numbers of cases averted annually through prevention of
progression to active disease and onward transmission directly impact on the number of TB
notifications annually.
Table 5. Prevention of progression to active TB, onward transmission and detection of active
disease over 10 years.
3
Model
3
Model
3
LTBI that did not progress to active disease
Target population
LTBI
population
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
10 yr Total
44481
8896
89
178
267
356
445
489
534
578
623
666
4224
Target population
LTBI
population
2012
2013
2014
2015
Prevention of onward transmission
2016
2017
2018
2019
44481
8896
36
71
107
142
Target population
LTBI
population
2012
2013
2014
2015
2016
2017
44481
8896
133
133
133
133
133
133
178
2020
2021
10 yr Total
231
249
266
1690
2018
2019
2020
2021
10 yr Total
133
133
133
133
1334
196
214
Active TB detected
Assuming a business as usual approach to TB service delivery TB notifications are forecast to rise year
on year in line with current trends to 47 per 100,000 by 2021. Implementing the active and latent TB
case finding programme results a reduction in TB notifications and rates reduce year on year as latent
TB is prevented from activating and less people are at risk of contracting infectious TB. The graph
below shows the potential impact of the case finding programme on TB rates over a 10 year period. By
2021 TB rates would decrease by a third to 27 notifications per 100,000 population if an active and
latent TB case finding was introduced in London.
Figure 1. TB rates over 10 years – business as usual vs. TB case finding programme
TB rate - Do nothing vs. Case finding Programme
50.0
TB rate per 100,000
45.0
40.0
35.0
30.0
25.0
20.0
2011
2012
2013
2014
2015
Do nothing
2016
2017
2018
2019
2020
2021
Case finding programme
60
Cost effectiveness
Cost effectiveness of the active and latent TB case finding programme is measured by quantifying the
cost and benefits of the current approach to TB service delivery versus implementing the TB case
finding programme.
Current TB service activity costs have been used to determine treatment costs avoided through cases
prevented progressing to active disease and onward transmission. Based on 2010 activity data from a
number of providers extrapolated across London costs of TB care are approximately £18.6 million per
annum. The average cost of treatment per TB case is approximately £3,500 – excluding costs
associated with investigating patients with TB symptoms that are not diagnosed with TB.
TB notifications are forecast to reach around 4080 notifications by 2021 equivalent to a TB rate of 47
per 100,000 population. Correspondingly treatment costs will rise from £18.6 to £22.9 million per
annum by 2021 (an increase of £4.1 million). Implementation of a TB case finding programme reduces
treatment costs to £13.4 million by 2021 (a decrease of £5.1 million from the current costs and £9.4
million from the ‘do nothing’ 2021 costs).
The TB case finding programme costs £6.1 million per annum. Over time, costs of the programme are
offset by a reduction in treatment costs. The TB case finding programme begins to pay for itself by year
six of the programme, as treatment costs for TB care decline. Figure 3 below shows the net costs for
TB care in London assuming the current approach to TB care versus the implementation of TB case
finding.
Figure 2. Total cost of TB treatment – with and without a case finding programme
25,000,000
20,000,000
15,000,000
2012
2013
2014
2015
TB case f inding
2016
2017
2018
2019
2020
2021
Do nothing
A business as usual approach to managing latent TB is the least expensive option in the short term but
results in the most cases of active TB. The cost effectiveness of the case finding programme increases
over time - in year one £6.1m prevents 125 cases of TB (£49,000 per case averted) but in 2021
prevents 907 case of TB (£6,700 per case averted). By year 10 of the case finding programme, net
costs will be £3.3 million less than a business as usual approach to TB care.
The case finding programme will also detect cases of active TB as found in the Hackney TB screening
pilot in Primary Care. Early detection of active TB disease reduces the duration of symptoms and fewer
61
hospital admissions compared to TB patients detected passively30. The savings gained by early
detection have not been factored into the this analysis due to difficulties quantifying the financial
impact.
Sensitivity analysis
Sensitivity analysis of the case finding programme included a number of variables – the target
population, progression rate to active TB and cost parameters.
At the upper end of the target population estimates, costs for the programme totalled £8.9 million per
annum but had a greater impact on rates, reducing them to 23 per 100,000 population by 2021. At the
lower end of the population estimates annual costs for the programme total £3.4 million and reduce the
rate to 32 per 100,000 population over the same period.
Costs for LES payments and IGRA fees were adjusted to higher rates with minimal impacts on the total
costs of the programme.
Treatment costs for latent TB are the largest cost and were revised to assess the cost of alternatives to
consultant led outpatient appointments. A nurse led approach to treatment management reduced total
costs of the programme from £6.1 to £5.4 million per annum.
The rate at which latent TB progresses to active tuberculosis is an important variable in determining the
impact of the case finding programme. Increasing the value over 7.5% increases the benefits of the
programme and costs effectiveness at each population range.
30
NICE. Tuberculosis: Clinical Diagnosis and Management of Tuberculosis, and measures for its prevention and control, 2011.
62
Appendix C: Risk assessment tool
Aim
The use of risk assessment tools identifies barriers to good TB care and treatment
completion.
Background
Demographic factors such as age, sex, ethnicity, education and socio-economic status
are not accurate predictors of adherence to TB treatment.
Factors which do predict non-adherence include the following:











History of previous TB treatment
Patients who have had AFB-positive sputum smears
History of homelessness (as defined in Enhanced Tuberculosis Surveillance)
History of drug or alcohol misuse (as defined in Enhanced Tuberculosis
Surveillance)
History of imprisonment (as defined in Enhanced Tuberculosis Surveillance)
Major psychiatric/memory or cognitive disorder
Denial of TB diagnosis
Confirmed or suspected drug-resistant TB – especially MDRTB
Too ill to self administer
All children (<16 years)
At patient’s request
The risk assessment forms have been developed by the London TB Workforce Group
(see attached) and a summary of the results are entered onto the LTBR (see attached
screenshot). This work is part of the TB Case Management Guidance Development
Group. Practice manual - Case management and cohort review of suspected and
confirmed TB cases (Draft Version 7 - January 2011).
Application
At the initial appointment the risk assessment should be conducted the same working
day and within 3 working days of first presentation to TB services for:



All suspected TB cases
All newly diagnosed TB cases
All patients prescribed preventive treatment
Directly observed therapy should be considered for all TB patients with active disease
who have been risk assessed with one of the factors in the list above.
0
The risk assessment forms usually used are Form 1 susTB and Form 2 ActTB with
other forms for use throughout the patient pathway. These forms are kept in the TB
patient’s notes.
Appendix D: Directly Observed Therapy protocol
Definition of Directly Observed Therapy (DOT): a trained health professional or
responsible lay person, supported by a trained health professional, observes the
patient swallowing every dose of medication prescribed for TB treatment. The DOT
worker completes a DOT log of medications observed and documents the visit.
Implementation of DOT
This document acknowledges the input of the Practice Manual, case management and
cohort review of suspected and confirmed TB cases currently under development.
The use of London TB metric 2 to risk assess TB patients contributes to this document.
Metric 2 states that the risk assessment tool is used to identify TB patients with one or
more risk factors who are less likely to be treatment compliant. The risks which patients
are assessed for are:

Use of drugs

Homelessness

Detention in prison (current and previous)

Alcohol

Mental health issues
TB treatment
TB treatment can be either self administered therapy where the drugs are taken daily
and are not observed or DOT. The use of DOT has been shown to reduce the rate of
drug resistance and relapse when compared with self-administered therapy.
DOT is part of a patient-centred case management approach, which may also include:
Support to attend medical appointments

Ongoing patient education

Offering incentives and/or enablers

Assisting with transport

Connecting patients with social services and other specialist support agencies as
appropriate
DOT is resource intensive and includes delivering the prescribed medication, checking
for side effects, watching the patient swallow the medication, completing a daily DOT
log of medications observed and incentives issued, documenting the visit and
answering questions.
Who should be offered DOT?
DOT should be considered for TB patients with active disease who are risk assessed
as requiring DOT to ensure treatment completion. Additional risks to those identified in
metric 2 can include:

Present or past poor adherence

History of previous TB treatment

Patients who have had AFB-positive sputum smears

Denial of TB diagnosis

Confirmed or suspected drug-resistant TB – especially MDRTB

Too ill to self administer

All children (<16 years)

At patient’s request
Wherever practically possible DOT should be initiated at start of TB treatment as
patients who are switched to DOT can see this as punitive measure and there is less
chance of successfully completing treatment. Both the DOT provider and treating
clinician should reinforce the value of DOT.
Patients not initially on DOT should be switched to DOT if there is:

Slow sputum culture conversion (culture still positive > 2 months after treatment
started) i.e. still infectious

Slow clinical improvement or clinical deterioration while on TB treatment

Side effects to medication and the patient is reluctant to self administer
All patients receiving DOT should sign a contract that states times and location for
DOT. The document includes the public health implications of not taking TB treatment
as prescribed. This agreement must be in a language understood by the patient and
included in medical records.
Who should observe DOT?
DOT is usually provided by a trained nurse or outreach worker from the local TB clinic.
In practice, DOT can be supervised by any responsible adult with the written consent of
the patient provided they receive direct regular support from the named case manager.
Other possible DOT workers include:

Nurses from other teams already visiting the patient

Non TB outreach workers

Homeless hostels (key workers)

Community pharmacists

Teachers

Staff working with offenders and ex-offenders

Staff working with clients who misuse drugs or alcohol

Staff working with people with mental health issues

Occupational health staff
All TB patients should have a named case manager. Responsibility to ensure that
effective arrangements are in place fro DOT and treatment completion remains with the
case manager.
Family members should only be included as DOT observers where, as a parent or
guardian, are able to supervise the treatment of children and younger adults in a
household and with support from the named case manager.
Where should DOT be provided?
Treatment should be arranged to be most practicable for the person with TB. DOT can
take place anywhere the patient, their case manager and DOT worker agree provided
the location is safe for both patient and DOT worker. When agreeing the DOT location
providers should consider issues associated with accessibility and economic resources
(incentives, enablers, travel costs, employment disruptions), other treatments currently
underway (HIV, methadone) and their locations, and possible social stigma associated
with having TB.
DOT provision based in a specialist TB clinic is the least resource intensive model but
will not be suitable for all patients. Community based DOT can be provided more
efficiently in partnership with health and social care services. TB clinics providing DOT
on an outpatient basis should have extended opening hours.
How frequently should DOT be provided?
The effectiveness of anti-TB drugs is dependent on adherence to prescribed therapy
and convenient dosing schedules are an important means to improve patient
adherence. Treatment may be given either daily or several times per week. The precise
dosing schedule should be determined by the prescribing clinician in collaboration with
the patient.
Where clinical management is complicated by the concurrent treatment of other
morbidities such as HIV or by opiate use then expert guidance should be sought.
Providing DOT for patients who are prescribed complex anti-TB drug regimens that
include intravenous, intramuscular or more than one daily dose is highly resource
intensive. TB services should aim to provide home care in collaboration with other
providers. Alternatively internet based technologies that enable DOT to be ‘virtually’
observed remotely have proved effective but requires support and weekly review.
How long should DOT be continued?
All patients commenced on DOT should complete their treatment with DOT. Where a
reduction in the frequency of contact with the DOT worker is planned the strategy is to
step down the dosing frequency after completion of the initiation phase of treatment. All
patients receiving DOT should complete the initiation phase of treatment before
reducing the level of treatment supervision. Where patients have demonstrated good
adherence and treatment is well tolerated it may be appropriate to step down from DOT
to SAT with weekly review.
How should patients who will not agree to DOT be managed?
The reasons for DOT refusal are that patients feel they could self-medicate and/or DOT
will interfere with their lifestyle. Usually these factors can be overcome by ensuring that
the arrangements for DOT are as convenient as possible for the patient.
Patients who require DOT can refuse DOT. The case manager must stress to the
patient the public health implications of not taking TB treatment. Patients who refuse
DOT should sign a written contract to self administer their treatment which should be
included in medical records. This must be in a language understood by the patient.
Sputum smear positive and/or drug resistant patients who present a clear threat to
public health and refuse DOT should be reported to the local Health Protection Unit TB
lead who should work with the case manager and patient in a multi-disciplinary case
conference to address the DOT issue. All patients who refuse DOT should receive a
high level of community support from their named case manager including weekly
adherence checks.
What is non-adherence?

Patients not on DOT are considered non-adherent after two consecutive missed
out-patient appointments.

DOT patients on daily therapy are considered non-adherent after missing 3 daily
doses or 2 doses per week in 2 consecutive weeks.

DOT patients on three times per week therapy are considered non-adherent after 2
or more doses are missed within two weeks.
All episodes of non-adherence must be documented and initiate action by the case
manager in consultation with the multi-disciplinary team to address any potential
barriers to treatment continuity.
Appendix D: TB cohort review guidance London
TB Cohort Review Guidance
London
HPA London Regional Epidemiology Unit
November 2011 – v2.0
Table of Contents
1 ............................................................................................................. Background
................................................................................................................................ 12
2 ............................................................................................... Aims and Objectives
................................................................................................................................ 13
3 ....................................................................................................... How is it done?
................................................................................................................................ 14
3.1
Preparation................................................................................................. 14
3.1.1
Organisation ................................................................................. 14
3.1.2
Setting outcome targets ................................................................ 15
3.2
On the day.................................................................................................. 15
3.3
Following the cohort review ........................................................................ 16
3.3.1
Dissemination of key data ............................................................. 16
3.3.2
Follow-up of issues raised ............................................................ 16
4 ........................................................................................................................ Roles
................................................................................................................................ 16
5 ..............................................................................................................Appendices
................................................................................................................................ 18
Appendix A: Standard Cohort Review Presentation Form....................................... 18
Appendix B: Cohort Review Incident Form .............................................................. 20
Appendix C: Outline of the ‘Introductory’ Presentation given by the epidemiologist 21
Appendix D: Outline of the ‘Outcomes’ Presentation given by the epidemiologist . 21
Appendix E: Standard Summary Report Form ........................................................ 22
Appendix F: Role of the Epidemiologist at Cohort Review ...................................... 24
This document was prepared by:
Charlotte Anderson and Sarah Anderson
HPA London Regional Epidemiology Unit
For further information please contact: [email protected]
Acknowledgements
Much of this document is based on material provided by the Centers for Disease
Control and Prevention (CDC) Division of Tuberculosis Elimination. This can be found
at: http://www.cdc.gov/tb/publications/guidestoolkits/cohort/default.htm
TB Cohort Review
Background
Cohort review was first used in Tanzania, by Dr Karel Styblo, and was implemented in
New York during the 1990s as a process to review treatment completion among TB
cases. Along with the introduction of other control measures, cohort review contributed
to an increase in completion rates, and a reduction in reported TB cases (particularly
MDR TB). It has been introduced to London, with the support of the London TB
workforce group and the joint working of the HPA and North Central London TB nurses,
and is now being rolled out across London.
Cohort review is a systematic quarterly review of the management of all TB patients for
treatment completion and contact investigation. The ‘cohort’ is a group of cases
counted over a specific time, usually three months.
Brief details of the management and outcomes of each case are reviewed in a group
setting. The case manager presents the cases for which they are responsible, giving
the opportunity to bring up problems and difficulties in case management, reveal
service strengths and weaknesses, and staff training needs.
Cohort review is an essential method of program evaluation and provides a multidisciplinary forum to review the management of each case and ensure accountability at
all levels of the service, while linking to local, regional and national targets.
While TB services differ in both TB epidemiology and service provision, the principles of
systematic review and accountability, that are central to the cohort review, are
applicable to any setting.
Aims and Objectives
Aims of cohort review:
1.
2.
3.
4.
5.
6.
To improve TB case management and identification of contacts
To improve treatment completion and contact investigation outcomes
To increase staff accountability for patient outcomes
To motivate staff
To reveal programme strengths and weaknesses
To indicate staff training and education needs
Objectives of the cohort review process are to:
1.
2.
3.
4.
Ensure the implementation of comprehensive TB case management procedures
Improve promptness of appropriate interventions
Maintain reliability of data on local and national TB Registers (ETS / LTBR)
Provide immediate analysis of treatment outcomes and contact investigation
efforts, measured against previous cohorts
5. Assess efforts compared to local and national TB control targets
6. Identify, track and follow up on important case management issues
7. Provide ongoing training and education for staff
How is it done?
Preparation
Organisation
All TB clinical networks or local TB service sectors should undertake a cohort review of
every active case of TB diagnosed during a given quarter of the year. The review
should be scheduled for each sector approximately six months after the close of each
quarter (so cases are presented six to nine months after starting treatment). An annual
schedule for the cohort reviews should be prepared and distributed by the cohort coordinator, who will arrange the facilities for the day. These should be attended by all
sector staff and other key allied professionals.
Two months before each cohort review, the cohort co-ordinator will produce a list of
cases for the current cohort by notifying clinic and send this list to the HPA London
Regional Epidemiology Unit who will prepare and distribute case presentation forms
(see Appendix A). The case presentation forms will be part completed with information
available on the London TB Register (LTBR). The cohort of cases should exclude
denotified cases. Case managers are responsible for completing the remaining parts of
each form and for updating the LTBR with any new information. In addition to the case
presentation forms, case managers should also complete ‘Cohort Review Incident
forms’ for any TB incidents involving HPU and extended contact tracing (see Appendix
B).
If any case has moved and is currently being treated by a different clinic, staff should
obtain the relevant outcome information from the new treatment provider. If the case if
part of a strain-type cluster or involved in an incident being managed by the local HPU
an update should be sought from the relevant parties ahead of the cohort review.
A preliminary run-through of case manager presentations may be helpful prior to the
first few cohort reviews and for any new staff. Support for case manager training for
cohort review is being offered by [email protected] specialist TB nurse at
HPA Colindale.
A week before the cohort review the epidemiologist will download updated LTBR data
and prepare a short introductory presentation of the cohort (see Appendix C). The
cohort co-ordinator will prepare a report of service issues raised in the previous cohort
review.
Setting outcome targets
In order to assess progress, targets must be set for outcomes which can be measured
at each review. Some targets will be set nationally, others may be regional or local.
Example outcome indicators for both case management and contact investigation are
given below. These indicators will be measured by the epidemiologist using data in the
TB surveillance system, and that presented on the day.
Case management
1. 100% of TB patients assessed as requiring DOT will be offered DOT31
2. >90% of TB patients will be offered HIV testing1
3. At least 85% of TB cases will successfully complete, or expect to
complete, a recommended treatment regimen within 365 days1. Treatment
outcomes will be reported separately for the following categories of
patients
a. patients receiving DOT from treatment onset
b. patients who have had AFB-positive sputum smears
c. patients with any first line drug resistance
4. Less than 1% of TB cases will be lost to follow-up at time of cohort review
Contact investigation
1. Among all pulmonary and pulmonary sputum smear positive cases:
a. At least 95% will have one or more contacts identified
b. At least 80% will have five or more contacts identified1
2. At least 90% of contacts of smear positive cases will receive clinical
evaluation1
3. At least 85% of contacts with LTBI who are started on treatment will
successfully complete, or will be expected to complete1
On the day
At the start of the cohort review, the cohort chair introduces the day. The cohort coordinator or medical reviewer will give a brief review of the service issues which arose
during the previous cohort, and the epidemiologist will provide a descriptive analysis of
the cases to be presented (the current cohort) and final outcomes of the previous
cohort.
Immediately following the epidemiologist’s presentation, the case managers will
present, in a predetermined order, each case in a clear and concise manner. Cases will
be prepared and presented using standard Cohort Review Presentation Forms which
will also be displayed electronically (if possible). The chair and medical reviewer are
responsible for raising questions about the management of each case, and ensuring
31
London TB metrics
standards of care were adhered to, although all those present are able to ask questions
or comment.
The epidemiologist will record at the time of the cohort review the known or likely
treatment outcome for each patient, and the outcomes of contact investigation, if not
already supplied to the epidemiologist ahead of the day. The data support analyst will
update, where necessary the clinical and demographic information on the LTBR for
each patient. The cohort co-ordinator will systematically document issues that arise
during the cohort review.
Immediately following the case presentations, the epidemiologist will calculate and give
a preliminary presentation of the cohort’s treatment completion data and contact
investigation outcomes as discussed at the time of the cohort review meeting (see
Appendix D).
Following the cohort review
Dissemination of key data
Data collected during the cohort review will be finalised and any subsequent
calculations tabulated and further analysed with respect to relevant targets as well as
compared to data from prior cohorts and other networks. The summary results will be
circulated to all attendees and other relevant members of the network within two weeks
of the cohort review, in a standard report (see Appendix E).
On an annual basis, a summary of all four cohort quarters for the year will be produced.
Follow-up of issues raised
Within two weeks of the cohort review, the cohort co-ordinator will disseminate the
issues that require follow-up to the appropriate TB service staff. Staff will be given one
month from the date this is sent to address issues identified during the cohort. The
cohort co-ordinator will send out reminders one week before responses are due to
ensure timely receipt of issues addressed.
Roles
The key roles required for cohort review are detailed below:
Cohort chair - (e.g. a senior and independent public health professional such as a
DPH, PH Consultant, CCDC or Regional Epidemiologist): chairs the meeting, questions
the case manager, raises case management and general service issues and uses
teaching opportunities.
Medical reviewer - (e.g. a Consultant Physician) reviews aspects of medical
management, collates service issues that arise, takes responsibility for ensuring
medical management issues are addressed and progress on these is fed back to staff.
Epidemiologist - presents epidemiological data including progress against outcome
indicators, using data already available in the LTBR, and that presented on the day,
some more detail of this role can be found in Appendix F.
Cohort co-ordinator - (e.g. lead TB nurse) determines cohort period and prepares
case lists for each review, trains and assists case managers in completing relevant
documentation, is responsible for time keeping on the day, co-ordinates follow up of
issues and data validation where necessary. An important role of this individual is to
ensure that all nurses are fully trained in how to present in a succinct manner for cohort
review and prior to the first few cohort reviews, may find it useful to run through the
presentations of a few cases to support the case managers’ preparation.
Case manager - completes relevant cohort review documentation and updates
LTBR/ETS with additional information, presents each case at the cohort review,
answers questions from colleagues, and asks questions/raises issues around patient
care. The primary case manager will present their own cases and is expected to have a
thorough knowledge of each case, as well as be able to respond to any question that
the chair might ask regarding these cases. All staff familiar with the case in question will
be expected to provide useful feedback concerning the management of the case.
Administrative support - supports the cohort co-ordinator to prepare for the cohort
review by booking a room, organising facilities to visually display the cohort review
forms (if possible), organises refreshments, sends invites to participants and informs
participants of any cases they are to present, requests return of completed cohort
review forms one week prior to the cohort review and prints a paper copy of all cohort
review forms for the cohort chair.
Data support analyst - prepares cohort review case forms from LTBR, notes and
updates additional clinical and demographic information on the LTBR for each patient
where necessary, often after the meeting.
Local HPU and other allied service staff (such as Find & Treat in London) should also
be present to respond to enquiries regarding incident contact investigation, TB cluster
updates, return to service efforts and advise on socially complex case management.
Appendices
Appendix A: Standard Cohort Review Presentation Form
Appendix B: Cohort Review Incident Form
Appendix C:
Outline of the ‘Introductory’ Presentation given by the epidemiologist at
Cohort Review
Cohort Review INTRO template for epi overview.ppt
Appendix D:
Outline of the ‘Outcomes’ Presentation given by the epidemiologist at
Cohort Review
Cohort Review OUTCOMES template for epi overview at end of CR.ppt
Appendix E: Standard Summary Report Form
Epidemiology report of [sector] TB cohort review Q[X] 20[XX]
Cohort review held on: [xx/xx/xxxx]
[epidemiologist]
Report prepared by:
XX TB cases were notified by [sector] clinics in Q[x] 20[xx].
[ADD anything to note from descriptive epidemiology of this cohort]
The following table summarises the outcomes of this cohort review for the
sector. Individual clinic outcomes are reported on the following page.
Table 1: Summary of key indicators for TB cases reported by [sector]
clinics Q[x] 20[xx]
All TB cases (XX cases):
Expected to complete treatment within 12 months
Lost to follow up at time of cohort review
Offered an HIV test
Cases requiring DOT offered DOT
Q[x] 20[xx] Target
(n) xx%
(n) xx%
(n) xx%
(n) xx%
85%
<1%
>90%
100%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
100%
95%
80%
90%
85%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
100%
95%
80%
90%
85%
Among pulmonary cases (YY cases):
Cases requiring DOT offered DOT
Have one or more contacts identified*
Have five or more contacts identified*
Contacts are clinically assessed**
Contacts with LTBI who start treatment successfully
complete**
Among pulmonary sputum smear positive cases (ZZ
cases):
Cases requiring DOT offered DOT
Have one or more contacts identified*
Have five or more contacts identified*
Contacts are clinically assessed**
Contacts with LTBI who start treatment successfully
complete**
*through household or incident screening
** house-hold contacts (not including incidents)
Table 2: Summary of key indicators for TB cases reported by [sector] Q[x] 20[xx], by clinic:
Clinic 1
All TB cases:
Expected to complete treatment within 12 months
Lost to follow up at time of cohort review
Offered an HIV test
Cases requiring DOT offered DOT
All Pulmonary cases:
Cases requiring DOT offered DOT
Have one or more contacts identified*
Have five or more contacts identified*
Contacts are clinically assessed**
Contacts with LTBI who start treatment successfully
complete**
Pulmonary sputum smear positive cases:
Cases requiring DOT offered DOT
Have one or more contacts identified*
Have five or more contacts identified*
Contacts are clinically assessed**
Contacts with LTBI who start treatment successfully
complete**
* through household or incident screening
** house-hold contacts (not including incidents)
Clinic 2
Clinic 3
Clinic 4
Clinic 5
(XX
cases)
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(YY
(YY case) (YY cases) (YY cases) (YY cases)
cases)
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(ZZ cases) (ZZ cases) (ZZ cases) (ZZ cases) (ZZ cases)
Target
(XX cases) (XX cases) (XX cases) (XX cases)
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
(n) xx%
85%
<1%
>90%
100%
100%
>95%
>80%
>90%
>85%
100%
>95%
>80%
>90%
>85%
Appendix F: Role of the Epidemiologist at Cohort Review
Introductory presentation
At the start of the cohort review the epidemiologist gives a short presentation on key
characteristics of the ‘current cohort’ compared to the last ‘cohort’. This is prepared using
LTBR data entered by clinics at the time of notification. The presentation includes;
 Outcomes of the previous cohort
The data collected at the previous cohort review on whether the patients are expected
to complete treatment within 12 months is compared to that actually recorded on
LTBR after 12 months since the patient was notified with TB. The reported reasons for
not completing treatment are shown, e.g. lost to follow up, died, transferred to another
clinic/overseas etc.
 Description of the current cohort
o Number of TB notifications by clinics
o Demographics of cohort - number and percentage of cohort by sex, median
age, ethnic group, country of birth, time since entry to UK
o Clinical characteristics – number and percentage of cohort with pulmonary
disease
o Risk factors – number and percentage of cohort with a history of homelessness,
history of drug use, UK prison history, mental health concerns, whose ability to
self-administer treatment is affected by alcohol. The number and percentage of
the cohort who have at least 1 risk factor and the number and percentage of
missing data on each risk factors by clinic
o Offer of HIV test - number and percentage of cohort by clinic and percentage of
missing data by clinic
o Cluster data – number and percentage of cohort that are part of a cluster,
percentage of which that are actively being investigated.
The above variables are compared to the previous cohort where appropriate.
Information collected at the cohort review
At the cohort review, data is recorded on variables not collected on the surveillance system
and data previously collected on LTBR is verified.
 The variables that are verified on each patient are - site of disease, sputum smear
positive status, risk factor data and use this to calculate if patient has more than 1 risk
factor, whether an HIV test has been offered, whether on DOT.
 The data that is collected on the day on each patient are – patient required DOT, the
expected treatment status at 1 year, number of contacts identified, number of contacts
assessed, number of contacts with active TB, number of contacts with latent infection,
number of contacts who started latent infection treatment, number of contacts who
completed latent infection treatment.
If the forms used by the case managers are returned to the epidemiologist prior to the cohort
review this data can be recorded before the day and the resulting presentation prepared.
Closing presentation
Using the data collected at the cohort review a presentation is prepared, either
simultaneously with the data being collected or previously if data is available prior to the
cohort review, and presented at the end of the cohort review. The data is presented by clinic
and for the sector. The presentation includes;
 Treatment outcome
o Number and proportion of cohort likely to complete treatment
o Reasons for not completing treatment e.g. still on treatment, died, lost to follow
up etc
o Number and proportion of deaths among cohort
o Number and proportion of cohort that are lost to follow up
 Outcome of contact tracing
o Contact tracing for pulmonary cases – contact index (average number of
contacts per case), percentage of cohort with >5 contacts identified,
percentage of cohort with 0 contacts identified, percentage of contacts
identified that are assessed, percentage of contacts that have latent TB
infection, percentage of contacts with active disease
o Contact tracing for pulmonary smear positive cases - contact index (average
number of contacts per case), percentage of cohort with >5 contacts identified,
percentage of cohort with 0 contacts identified, percentage of contacts
identified that are assessed, percentage of contacts that have latent TB
infection, percentage of contacts with active disease
 Overall summary of case management outcomes
The following variables are presented against previously agreed targets, the targets
below are those set across London.
o Percentage of cohort assessed as requiring DOT offered DOT - target 100%
o Percentage of cohort offered an HIV test – target >90%
o Percentage of cohort who successfully complete, or are expected to complete,
treatment within a year - target >85%
o Percentage of cohort lost to follow-up at time of cohort review – target <1%
 Summary of contact investigation
Calculate separately for both pulmonary and pulmonary smear positive cases
o Percentage of cohort with one or more contacts identified – target >95%
o Percentage of cohort with 5 or more contacts identified – target >80%
o Percentage of contacts identified that were assessed – target >90%
o Percentage of contacts with LTBI who started on treatment and successfully
completed, or will be expected to complete – target >85%
The above variables are compared to the previous cohort where appropriate.
Following the cohort review
An epidemiology report is prepared using the data collected on the day and sent to all those
that attended the cohort review (see Appendix E).