FAQs

INTRODUCTION

These Frequently Asked Questions (FAQs) are based on issues raised by patients and carers during the formal testing and piloting of the new patient information leaflet. They are intended to be useful to patients who, having read the leaflet, would like more information about the cancer registration scheme. They are also intended to provide additional background information for health professionals as an aid to dealing with any issues raised by patients.

Cancer registries for many decades operated on the principle of implied consent. This was in line with the contemporary NHS guidance on confidentiality. It was assumed that patients were willing for information collected about their illness and treatment to be used for legitimate purposes other than direct patient care. The implementation of the Data Protection Act (1998) and the publication of guidance from the General Medical Council in 2000, however, raised concerns about the validity of a system based on implied consent and highlighted the need to have a clear legal basis for the cancer registration system if it was to continue without explicit consent from individual patients.

The law that now covers the operation of the national cancer registration scheme in England and Wales is the Health and Social Care Act 2001. Section 60 of the Health and Social Care Act 2001 gives the Secretary of State for Health the power to ensure that patient identifiable information needed to support essential NHS activity can be used without the consent of patients. The power can only be used to support medical purposes that are in the interests of patients or the wider public, where consent is not a practicable alternative and where anonymised information will not suffice. It is intended largely as a temporary measure whilst consent or anonymisation procedures are developed, and this is reinforced by the need to review each use of the power annually.

In 2002 the United Kingdom Association of Cancer Registries sought, and obtained, approval under Section 60 (Regulation 2) to continue to use patient-identifiable data for cancer registration. This was approved by Parliament on 23rd May 2002 and came into effect on 1st June 2002.

Specifically, Regulation 2 makes provision for “the processing of confidential patient information in connection with the construction and maintenance of databases by bodies (known as “cancer registries”) which undertake the surveillance of health and disease of patients referred for the diagnosis or treatment of neoplasia” [cancer]

Under the Act, a new independent body known as the Patient Information Advisory Group (PIAG) was established:

• To advise the Secretary of State for Health on regulations which should be
  made under Section 60 of the Health & Social Care Act
• To advise the Secretary of State as required on the use of patient information.
  PIAG’s role is to scrutinise carefully applications to use patient identifiable
  information made under Section 60 and to make recommendations where the use of
  the information requires Regulations to be laid before parliament or to approve
  applications, on behalf of the Secretary of State for Health, where the use of the
  information is limited to certain categories. PIAG also undertakes an annual review of
  each successful application to check whether the requirement to use identifiable data
  without consent is still valid.

For further information see: www.advisorybodies.doh.gov.uk/piag/Index.htm

In the past, it was assumed that the there was a sufficiently strong public interest
justification to use health information for purposes other than direct patient care
without consent. With the Data Protection Act, it was clear that there is a
responsibility to inform patients about specific uses of health information for purposes
such as cancer registration. Cancer Registries have taken responsibility for producing
a standard national leaflet explaining the cancer registration scheme and for working
with cancer networks and the Department of Health to ensure that in future the leaflet
is made available to all cancer patients.

At the first annual review of the Section 60 regulation covering cancer registration
(see Question 1 for an explanation of what this means), the Patient Information
Advisory Group (PIAG) reinforced the requirement for cancer registries to develop a
communication policy to inform patients of their work, to advise them that
registration is automatic following a cancer diagnosis, and to describe what personal
information will be held and how it will be used. It requested that any information for
patients should be tested with patient groups. During 2004, the leaflet has been tested
with small groups of cancer patients and parents of children with cancer and with
some representatives of national cancer patient groups. The leaflet has also been
checked by the Plain English Campaign and the Centre for Health Information
Quality (CHIQ) to ensure it can be understood by the average person. The leaflet is
now ready for use and is being rolled out across the country.

A wide range of information is collected, in keeping with the many uses described in
the answer to Question 8. This includes the name, address, gender, date of birth, and
NHS number of the patient, the type and location of the cancer, how advanced the
cancer is, and the treatment received by the patient. Unlike the system for certain communicable diseases, the registration process for
cancer is not usually based on notifications from individual clinicians. Instead, cancer
registries receive routine (often electronic) notifications from a variety of sources.
These sources include district general hospitals, cancer centres, hospices, private
hospitals, cancer screening programmes, other cancer registers, primary care, nursing
homes and death certificates. Data are frequently received from several sources within
an individual institution (e.g. pathology departments, medical records and
radiotherapy databases). Increasingly the main sources of data for cancer registries are
computerised hospital systems within pathology, oncology and other departments.[reveal]

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5. Why is it necessary to collect identifiable information?

Answer"]There are five main reasons why, at present, it is necessary to collect information that
identifies patients.

• Patients often attend more than one hospital. It is important to know that a
  cancer reported from a number of different hospitals relates, in fact, to the
  same person, otherwise registrations would be duplicated and cancer incidence
  rates would appear to be misleadingly high.
• An important indicator of the effectiveness of cancer services is the percentage
  of patients who survive their cancer. It would not be possible to link a
  patient’s date of death to their cancer records without identifying information.
• People are often concerned that there might be a high risk of cancer in their
  locality. These risks cannot be investigated properly without knowing where
  patients with cancer live (based on postcode of residence).
• People are often worried that their family history may put them at high risk of
  cancer. An accurate family history is crucial if these individuals are to be
  offered appropriate advice. The cancer registry is often asked by clinical
  geneticists to confirm the details of a cancer diagnosis in a relative of someone
  attending their clinic. In the case of living relatives, this information is only
  released with the written informed consent of the relative concerned. Often,
  especially when medical records have been destroyed, the cancer registry is
  the only available source of such information.
• Occasionally, a previously unforeseen, significant late effect of therapy comes
  to light many years or even decades after that treatment was in widespread
  use. In these circumstances, it will be necessary, using all available
  information sources including the cancer registry, to try and trace all patients
  who might be at risk, so that they can be informed and counselled about
  possible interventions to reduce their risk.

Cancer registries do use the NHS number to link records whenever possible. Although
the NHS number has almost 100% coverage in England and Wales, not everyone’s
number can be traced and it still does not appear on every document produced in
hospitals, e.g. pathology or radiology reports. Some patients might not therefore be
registered, resulting in incomplete statistics. The NHS number consists of 10 digits
and can very easily be mis-transcribed, which would lead to inaccurate data being
recorded, possible duplication and the inability to link information to the correct
patient. The use of the NHS number should improve over the next few years as it
becomes more widely used to link records across the NHS as part of the work being
undertaken by NHS Connecting for Health (previously called the National
Programme for Information Technology). This should allow a further reduction in the
use of identifiers other than NHS number by cancer registries. The UK Association of Cancer Registries has produced a set of guidelines governing
the release of data to outside parties, which has been approved by the Patient
Information Advisory Group (PIAG). Identifiable data are shared between cancer
registries and can be released to organisations (hospitals, primary care trusts and
cancer networks) and individuals (doctors) providing care for those patients. They are
only released to bona fide medical researchers who can justify the use of identifiable
data and who have made application to, and been approved by the relevant Medical
Research Ethics Committee and been granted Section 60 support through PIAG.

The UK Association of Cancer Registries confidentiality guidelines can be found at
www.ukacr.org

Cancer registries undertake a range of public health surveillance and health
protection functions. The main functions of cancer registries are:

• monitoring trends in cancer incidence, prevalence and survival over time and
  between different areas and social groups
• evaluating the effectiveness of cancer prevention and screening programmes
  For example, population based data are required to monitor the effectiveness
  of the existing national screening programmes for breast and cervical cancer
  and to inform the design of new programmes, e.g. screening for colorectal
  and ovarian cancer
• evaluating the quality and outcomes of cancer care by providing comparative
  data about treatment patterns and outcomes
• evaluating the impact of environmental and social factors on cancer risk. For
  example, cancer registry data are used to investigate possible cancer risks in
  relation to power lines, landfill sites and mobile phones.
• investigating differences in cancer incidence, survival and access to
  treatment between social classes and thus contributing to programmes aimed
  at reducing health inequalities
• supporting investigations into the causes of cancer
• providing information in support of cancer genetic counselling services for
  individuals and families at higher risk of developing cancer.

This is best summarised by listing some examples of what we know as a result of
the work of cancer registries and what we will not know in future if cancer
registration data become unreliable.

What we know as a result of information obtained from cancer registration:

• mesothelioma is caused by exposure to asbestos
• skin melanoma rates have been increasing year on year
• lymphoma and oral cancer rates are higher in ethnic minorities
• there is wide variation in how cancer is treated around the country
• cancer survival for patients living in poor areas is lower than for those living
  in rich areas
• cancer survival is lower in the UK than in Europe for most cancers
• cancer survival in children has improved dramatically over the last 30 years.

What we may not know in future if cancer registration becomes unreliable:

• how many cancers occur each year, and which are the most common
• whether cancer rates in the UK are increasing or decreasing
• if cancer incidence rates in the UK are higher or lower than in other
  countries
• if cancer survival rates in the UK have caught up with other European
  countries
• if inequalities in cancer treatment or survival between rich and poor have
  been reduced
• if cancer screening programmes are effective
• if people living near landfill sites or power lines have an increased cancer
  risk
• whether some late deaths in childhood cancer survivors are related to earlier
  treatments
• if the risk of developing certain cancers is higher in some occupational
  groups.

Patients have the absolute right to opt out of the cancer registration scheme if they
wish to do so. There are several things that must be understood when taking this
option.

Ideally this would be achieved by the flagging of all their cancer-related records on
all computer (and manual) systems feeding the cancer registry to prevent any records
from being sent to the registry once the patient’s objection was recorded. In practice,
it is not currently possible to do this because of the limitations of hospital computer
systems.

Currently, the most viable alternative is for the cancer registry to retain a record of the
person’s identifying details (the NHS number should be sufficient) without any
clinical details attached so that any relevant records held by the cancer registry or
received at a later date can be deleted. This arrangement and the reasons for it must
be explained to the patient and, assuming they agree, their identifying details should
be supplied to the cancer registry.

Some patients might be willing to have their details recorded on the cancer register
and used to contribute to local and national statistics about cancer and for other
purposes including research that does not involve patient contact. They might wish
only to opt out of the possibility of being included in any research projects involving
direct contact with patients. If this is the case, the regional registry will flag the
patient’s cancer registration records to ensure that their details would never be
released to researchers for any research project involving patient contact.

However, if a patient wishes to have their entire record deleted, this wish must be
respected. In such cases it must be made absolutely clear to the patient that without
retaining their NHS number in the registry, the risk of re-registration from other
sources is highly probable.

Patients have the right to be informed about the processing and uses of their
information, and the right to object to their information being used in certain
circumstances. When a patient expresses a wish to “opt out” of cancer registration, it
is important that they understand what the cancer registry is, what information is
collected, and what the information is used for. It is important for patients to be fully
informed of the potential consequences of their “opting out” before they make this
choice. It must also be made clear, however, that this will not affect their treatment
and care.

For example, the decision to “opt out” may have

• implications for them personally – for example, it may not be possible to
  identify them as being at risk in future patient notification exercises.
• implications for their descendants – who may be deprived of complete
  information on their family history of cancer, leading to an inaccurate
  assessment of their risk, and the possibility of inappropriate management.
• implications for society – since the more people who choose to “opt out” of
  having their information included, the less useful the information becomes (for
  example, in the context of investigating a possible cluster of cancer, or
  identifying a problem with cervical screening or cancer treatment services).

It is also important to bear in mind that the use of cancer registry data to support
genetic counselling and patient notification exercises is a relatively recent
development that was not anticipated 15 years ago. It is not possible to predict other
future potential uses of the data that might also place at a disadvantage patients who
choose to “opt out”. While it is important to consider the potential disadvantages to
the patient (and society) of “opting out”, patients should not feel pressured into
agreeing to registration.[reveal]

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12. If a patient or health professional wants more information about how the
cancer registration scheme works in their local area or has any concerns they
would like to discuss, whom do they contact?

Answer"]If a patient or health professional would like to know more about the cancer
registration scheme or would like to discuss any concerns with their regional cancer
registry, the appropriate registry can be identified by selecting either the hospital of
treatment or typing in the postcode for the patient’s place of residence using the
Registry Finder at the end of this section

If a patient has been treated in more than one hospital and the hospitals are in areas
covered by different registries or if the patient lives in an area covered by one registry
but was treated in a hospital covered by another, the patient or health professional
need only contact one (either one) of the registries. The registries have undertaken to
communicate with each other about any cross-over issues and to ensure that a patient
wishing to opt out of the cancer registration scheme only has to deal with one body.

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13. If a patient wants to opt out of the cancer registration scheme, what do they
have to do?

Answer"]If a patient wishes to opt out of the cancer registration scheme they should contact the
Director of the Cancer Registry for their local area or ask their doctor to do this on
their behalf.