Clinical Research Network
Primary Care
Research Codes for Primary Care
February 2017
Delivering research to make patients, and the NHS, better
Contents:
1.
Introduction
2.
Background
3.
New terms explained/patient’s pathway through a study
4.
How to use the codes in practice
5.
Frequently asked questions?
What if I don’t know the CPMS ID?
How do I know whether to use the codes for a “research study”, or those for a
“clinical trial”?
When would I use ‘Consented to medical record review’ code?
Appendix 1: Complete list of codes
1
1. Introduction
Clinical coding of patient consultations is standard practice in primary care settings, however
the use of codes for research purposes in general practice has to date been variable.
Research is part of core business within the NHS, so it is essential that NHS staff are equipped
with the tools they need to allow them to code research activity appropriately.
The NIHR Clinical Research Network (CRN) supports the delivery of studies in secondary and
primary care settings and specifically in the latter supports primary care professionals to be
able to participate in research delivery.
This guidance incorporates the work the former Primary Care Research Network (PCRN)
Read Code Working Group undertook to enable research activity to be coded in general
practice computer systems in a clear and consistent way.
2. Background
The PCRN Read Code Working Group identified a need for a set of generic research codes
(which could be made specific to an individual study by using a study ID as the code value)
for recording research activities in primary care and clear benefits were identified for primary
care sites, the CRN and research teams. The key benefits are:
Benefits for primary care sites
●
●
●
●
●
Patient identification
Research codes enable easy identification of patients approached about or entered
into studies. Use of such codes ensures a coded record of research participation
remains in the patient’s lifelong electronic patient record wherever they transfer to in
UK, making patient follow-up easier.
Preventing multiple approaches
By coding patients who have been invited to take part in a study, practices can ensure
that patients aren’t sent multiple requests to take part in the same study, or in different
studies. However, multiple approaches may be appropriate but practices will be able
to monitor this activity.
Safety
Coding of research participation will enable primary care teams to quickly identify
patients who need to be contacted about a specific study.
Administration
The use of research codes can reduce paperwork, save time, help practices monitor
their research, ensure that research activity recorded in the patient record is easier to
search for (and interpret and interrogate), and reduce the need for free text entry of
research activity (which can be difficult and slow to analyse). National research codes
allow future proofing of coding, as systems develop and change and data is migrated
across systems.
Other
The use of research codes will be helpful for audit purposes: making it an easier
process and improving data quality.
2
Benefits for the NIHR CRN
●
●
●
●
Aid mapping of activity
Ensuring practices are in a better position to track their activity so they can provide
more accurate information to the network.
Assist with payment of NHS Service Support Costs (SSCs)
As practices will be able to better track their activity, networks will be able to ensure
more accurate and timely payments of SSCs.
Patient Identification Centre (PIC) work/screening
Using codes to flag patients who were contacted about taking part in a study will
allow practices to capture PIC activity. Research codes could also be used to identify
patients participating in specific studies (for example, if participation in one study is
an exclusion criterion for another study)
Recruitment
Recruitment during consultations can be enhanced by using clinical codes to trigger
pop-up templates to alert clinicians about a study the patient may be eligible for.
Research codes then allow the decisions from discussing a study to be recorded (for
example, declined to participate in XX study, not eligible for YY study)
Benefits for researchers
●
●
●
Data collection
Practices will be able to identify patients who are participating in studies more easily.
So making it easier to provide research data to research teams, and for these data to
be accurate and the data returns speedy. Specific research codes for individual study
activities will be need for these purposes.
Tracking patients
Research codes will allow easier tracking of patients participating in specific studies
making follow up easier.
Generic research codes
Generating new national codes takes at least six months and using generic research
codes with a study ID in the value field obviates the need to generate a new set of
codes for each new study.
A generic set of research codes, which can be made specific to an individual study, has been
developed and approved for national use, and this guidance aims to support practice staff and
researchers in their use. Further work is underway to establish whether the use of a generic
research template may also be beneficial.
The NIHR CRN provides support to high-quality clinical research studies. All the studies which
it supports must meet the eligibility criteria outlined by the Department of Health. All eligible
studies will be recorded on the NIHR CRN Central Portfolio Management System (CPMS)
database and visible via the website; https://www.ukctg.nihr.ac.uk/. All studies on the CPMS
database have a unique study identifier (CPMS ID), a 4-6 digit number which can be used to
identify the project. These unique identifiers can be used alongside the generic research codes
3
(as code values) to enable NHS staff to code research and link it to a specific study. This
guidance document will outline how these codes may be used in practice.
3. New terms explained/patient’s pathway through a study
The code terms outlined below should be used when coding research activities taking place
at the site.
The list below is a simplified version containing the terms, their definition and examples of
when to they can be used. The full list of the new codes depending on the practice system
you are using is available in Appendix 1.
The full list consists of two sets of codes – one to code research activity concerning a “research
study” and one to code a “clinical trial”. Each set covers the same points in the patient pathway
illustrated below and contains the necessary SNOMED, Readv2 and CTV3 codes. Which set
is used will need to be decided by the study team, to make sure there is consistency in coding,
but in general the “clinical trial” set will be applicable for randomised trials of medicinal
products, medical devices or other new interventions, whereas the “research study” set will be
applicable for observational studies.
Patient’s pathway through a study
Possibly Eligible (A)
Ineligible (C)
Eligible (B)
Invited (D) /Referred (E)
Declined (F)
Clinical Assessment
Performed (N)
Consent to participate
(G) / Consent to medical
record review (H)
Participating (I)
Follow-up (K)
Withdrawn (J) /
Lost to follow-up (M)
4
Complete (L)
Requirement
Pathway
index
(A)
Term
Possibly eligible
for participation in
research study
Research study –
screened
[Patient
potentially
eligible for the
study (e.g.
record flagged
by a MIQUEST
query)]
(B)
(C)
Eligible for
participation in
research study
Not eligible for
participation in
research study
Definition
This code should be used at the
point at which the patient has
been deemed suitable to
approach about the study.
This does not necessarily mean
that the patient has met all the
inclusion/exclusion criteria.
This code should be used when
inclusion/exclusion criteria have
been met and the patient is
deemed eligible to take part.
This may be before or after
informed consent has been taken
depending on the study.
Patients who were considered for
the study but haven’t met all the
inclusion/exclusion criteria.
5
Example of when it may be used
Record flagged following a database search using criteria
provided by the study team. Patient presents in clinic with
relevant symptoms for study.
(patient records can be updated automatically by the GP
system or the query)
All eligibility criteria have been determined through the
database search and patient is confirmed eligible.
Patient has completed all screening checks and has been
deemed eligible.
(patient records can be updated by the admin staff in the
practice)
Patient was invited to take part, consent was taken but results
of ECG make them ineligible.
Patient sent letter of invitation as they met clinical criteria but
they don’t have access to the internet so deemed ineligible.
(patient records can be updated by the admin staff in the
practice)
Requirement
Research study –
invited
Research study –
referred
Research study –
declined
Research study –
consent to
participate given
Pathway
index
Term
(D)
Invitation to
participate in
research study
(E)
Referral for
participation in
research study
(F)
Declined invitation
to participate in
research study
(G)
Consent given to
participate in
research study
Definition
Example of when it may be used
Patient invited to take part in the
study (e.g. invitation letter sent)
This code may be used at the point the patient is provided with
information about a study. This may be via a letter of invitation
sent in the post, a face to face discussion, the receptionist
handing out a leaflet, a telephone call from the practice to the
patient etc.
(patient records can be updated by the admin staff in the
practice)
Patient referred to another site
(P.I.C. activity only)
This code will be used when details of an interested patient are
passed onto another NHS site or to the research team.
(patient records can be updated by the admin staff in the
practice)
Patient did not consent to the
study
Use this code when a patient has confirmed that they do not
wish to take part in the study. This may be a verbal or written
message from the patient.
(patient records can be updated by the admin staff in the
practice)
Patient signed the consent form
for the study
This code should be used when the patient has given informed
consent, either written consent but in some cases this may be
verbal consent.
(patient records can be updated by a GP during consultation or
admin staff in the practice)
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Requirement
Research study –
consented to
medical record
review
Research study –
participating/on
study
Research study –
withdrawn/off
study
Research study –
in follow up
Pathway
index
(H)
(I)
(J)
(K)
Term
Consent given to
review medical
record in research
study
Participant in
research study
Withdrawn from
research study
Research study
follow-up
Definition
Example of when it may be used
Patient’s medical records can be
used in research.
This may be used for studies where the patient may have
consented in another organisation and a copy of the consent
form is sent to the practice with a request for information from
the medical notes.
(patient records can be updated by the admin staff in the
practice)
Patient actively participating in
the study (e.g. attended first
assessment and continues
participating)
This can be used when the patient attends the practice for a
study visit or if the practice want to code information sent about
the patient’s participation from the study team. For example the
study team may send a letter informing the practice that the
patient has undergone a test specifically relating to the study.
(patient records can be updated by a GP during consultation or
admin staff in the practice)
Patient withdrawn from the study
– no longer participating
The code can be used if you are made aware that the patient
has chosen to withdraw from taking part in the study. You may
be informed by the patient or by the study team or the site the
patient has been referred to.
(patient records can be updated by the admin staff in the
practice)
Patient in follow-up stage
This may be used if the patient was attending a follow up visit
or a follow up phone call took place, or if you received a letter
informing that patient had undertaken a follow up visit at
another site. You may also like to use this code if you were
providing data for follow up purposes without the patient being
present. (patient records can be updated by the admin staff in
the practice)
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Requirement
Research study –
completed/off
study
Research study –
lost to follow-up
Research study –
clinical
assessment
performed
Pathway
index
Term
Definition
Example of when it may be used
Participation in
research study
completed
Patient completed all the
assessments for the study
This code should be used at the end of the study when all
study procedures including follow up have been completed. In
some cases’ this will be a notification from the study team.
(patient records can be updated by the admin staff in the
practice)
(M)
Lost to research
study follow-up
Patient moved practices/changed
address while on the study –
cannot be tracked by the study
team and/or GP
Use this code when you are no longer able to contact the
patient for study purposes. When confirmed LtFU (Lost to
Follow-Up)
(patient records can be updated by the admin staff in the
practice)
(N)
Research study
observation activity
Procedure/test/consultation as a
part of the study
Use this code when a study procedure has taken place. For
example, a blood test, ECG, measurements of height and
weight, blood pressure, questionnaire, vaccination given.
(L)
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4. How to use the codes in practice
When you are ready to enter a code you can use the table (page 5) and/or pathway (page 4)
to identify the requirement and identify the correct code for your practice system
e.g. if a patient has just signed the informed consent form to take part in a clinical trial, the
term to use would be “Research study – consent to participate given”, or “Patient
consented to clinical trial”, the latter if “clinical trial” codes are being used for the study. You
could alternatively enter a synonym to bring up the full list of terms and codes and then select
the most appropriate term/code from the list.
To then link the patient to a particular study you must then enter the study CPMS ID1.
Examples
Research Study A (CPMS ID 12345)
 Uses GP database search to identify patients and confirm eligibility
 GP Practice sends letters of invite to potential participants
 Interested patients reply directly to the study team
 Study team informs the practice who has agreed to take part in the study
Research Study coding example A
All codes need to have a correct study number as an attribute
Database search performed to
identify patients for research study
No GP action required
– query can be run by
PM or research officer
No GP action
required – records
updated
automatically
No GP action
required - data can
be updated by
practice admin staff
or practice nurse
Identified records are coded as:
(B) Research study – screened,
eligible for participation in
research study code entered
into the patient’s record
Practice sends invitation letter and
records of addresses are coded as:
(D) Research study – invited,
Invitation to participate in
research study.
1
The study team will inform the GP
of those patients who agree to
take part.
Practice to update patient record
and add code:
(I) Research study –Participant
in research study
The ways of finding the CPMS ID (portfolio ID) for a study are described in detail in the Frequently Asked
Questions section
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Study B (CPMS ID 98765)







Patient arrives in GP office with symptoms making them potentially eligible.
GP hands out patient information sheet and asks patient to make another appointment
if they are interested
Patient returns to clinic and wants to take part.
Informed consent is taken by GP. Patient then see’s the practice nurse who completes
remaining screening tests – blood pressure check and questionnaire.
Patient is confirmed as eligible to take part in the study and nurse calls study team to
randomise patient.
Patient randomised to arm C and is allocated treatment x.
Patient is to be seen every month for next 3 months. Each visit will consist of blood
pressure, questionnaire and medication compliance check. At last visit only patient
will also have a ECG.
No further patient visits but study team would like GP to fax medical notes review
data at 6 months after data of randomisation. No further activity – patient off study.
Clinical Trial coding example B
Patient is randomised to arm C and allocated
treatment X – no code required
After handing patient information sheet
patient’s record is coded as:
Each study related visit is recorded in the
patient’s file as:
(D) Clinical trial – invited, Invitation to
participate in clinical trial code
(N) Clinical trial – Clinical trial observation
activity code
During the next visit patient signs the consent
form and GP enters:
After completing all study visits the patient’s
record gets updated with:
(G) Clinical trial – consent to participate
given, Patient consented to clinical
trial code
(K) Clinical trial – in follow-up, Clinical
drug trial follow up visit code
After completing the screening tests,
questionnaire and confirming eligibility, the
practice nurse enters
After sending follow-up data to the study
team GP or practice nurse enters:
(B) Clinical trial – screened, eligible for
participation in clinical trial code
Data can be updated by
a GP or practice nurse
(L) Clinical trial – Completed clinical
trial code
No GP action required – data
can be updated by practice
admin staff or practice nurse
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No action required
Study Y (UKCRN ID 4444)
Study team are looking to get survival status at 2 years on all their patients who were recruited
to study Y. If they are alive at 2 years then an additional questionnaire will be sent. A search
of all patients who consented to study Y can be performed to identify patients. Those patients
who are alive can then be highlighted and sent the questionnaire.
No action required
No GP action
required – data can
be updated by
practice admin staff
or practice nurse
Study team contact the
practice where the study Y
ran 2 years ago
Practice staff runs a search for
all participants who took part
in the original study – all
‘Research study – consent to
participate given’ codes
(9QL..) with value 4444.
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Patients who can be contacted
(alive) are being sent letters
with follow-up
questionnaires.
5. Frequently asked questions?
What if I don’t know the CPMS ID?
There are a number of different ways you can identify the CPMS ID for a study:




If you haven’t received the CPMS ID with the study details, you can contact your
Local Clinical Research Network
You can use the UK Clinical Trials website: https://www.ukctg.nihr.ac.uk/
You can search for the study on CRN’s Open Data Platform:
http://public-odp.nihr.ac.uk/
Alternatively, you can contact CRN coordinating centre at
[email protected] or by calling 01133434555.
How do I know whether to use the codes for a “research study”, or those for a “clinical
trial”?
The study research team (ultimately the Chief Investigator) is responsible for deciding which
set of codes should be used to record the research activity relating to a specific study or trial.
The codes to use to record research activity for a specific study should be specified in the
study protocol and the information provided to sites which are participating in the study. If there
is any doubt network staff or site staff should check with the study research team.
When would I use ‘Consented to medical record review’ code?
This code can only be used when a patient has given consent in a specific study for their
medical record to be accessed as specified in the Participant Information Sheet for that
study.
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Appendix 1: Complete list of codes
Requirement
Index
Definition
(A)
Patient
screened
(B)
(C)
Patient potentially
eligible for the
study (e.g. record
flagged by a
MIQUEST query)
Research Study Code
Clinical Trial Code
SNOMED - 871801000000106 | Possibly eligible for
participation in research study (finding) |
CTV3 - XaaEG | Possibly eligible for participation in
research study |
Read V2 - 9QH.. | Possibly eligible for participation
in research study |
SNOMED - 872341000000109 | Possibly eligible
for participation in clinical trial (finding) |
CTV3 - XaaEl | Possibly eligible for participation in
clinical trial |
Read V2 - 9P7.. | Possibly eligible for participation
in clinical trial |
SNOMED - 873131000000106 | Eligible for
participation in research study (finding) |
CTV3 - XaaFh | Eligible for participation in research
study |
Read V2 - 9QJ.. | Eligible for participation in
research study |
SNOMED - 399223003 | Patient eligible for clinical
trial (finding) |
CTV3 - XaaFi | Eligible for participation in clinical
trial |
Read V2 - 9P8.. | Eligible for participation in
clinical trial |
SNOMED - 873751000000103 | Not eligible for
participation in research study (finding) |
CTV3 - XaaGx | Not eligible for participation in
research study |
Read V2 - 9QK.. | Not eligible for participation in
research study |
SNOMED - 444734003 | Does not meet eligibility
criteria for clinical trial (finding) |
CTV3 - Xaa7Z | Does not meet eligibility criteria for
clinical trial |
Read V2 - 9PD.. | Does not meet eligibility criteria
for clinical trial |
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Requirement
Patient
invited
Patient
referred
Patient
declined
Patient
consent to
participate
given
Index
(D)
(E)
(F)
(G)
Definition
Research Study Code
Clinical Trial Code
Patient invited to
take part in the
study (e.g.
invitation letter
sent)
SNOMED - 871271000000102 | Invitation to
participate in research study (procedure) |
CTV3 - XaaDW | Invitation to participate in research
study |
Read V2 - 9Q9.. | Invitation to participate in
research study |
SNOMED - 503151000000105 | Invitation to
participate in clinical trial (finding) |
CTV3 - XaQHW | Invitation to participate in clinical
trial |
Read V2 - 9P4.. | Invitation to participate in clinical
trial |
Patient referred to
another site (P.I.C.
activity only)
SNOMED - 871291000000103 | Referral for
participation in research study (procedure) |
CTV3 - XaaDX | Referral for participation in
research study |
Read V2 - 9QA.. | Referral for participation in
research study |
SNOMED - 873161000000101 | Referral for
participation in clinical trial (procedure) |
CTV3 - XaaFj | Referral for participation in clinical
trial |
Read V2 - 9P9.. | Referral for participation in
clinical trial |
Patient did not
consent to the
study
SNOMED - 871361000000100 | Declined invitation
to participate in research study (finding) |
CTV3 - XaaDb | Declined invitation to participate in
research study |
Read V2 - 9QB.. | Declined invitation to participate
in research study |
SNOMED - 399250008 | Patient declined clinical
trial (finding) |
CTV3 - XaaFk | Declined to participate in clinical
trial |
Read V2 - 9PA.. | Declined to participate in clinical
trial |
Patient signed the
consent form for
the study
SNOMED - 873771000000107 | Consent given to
participate in research study (finding) |
CTV3 - XaaGy | Consent given to participate in
research study |
Read V2 - 9QL.. | Consent given to participate in
research study |
SNOMED - 399174000 | Patient consented to
clinical trial (finding) |
CTV3 - XaN0L | Patient consented to clinical trial |
Read V2 - 9PC.. | Patient consented to clinical trial
|
14
Requirement
Patient
consented to
medical
record review
Patient
participating/
on study
Patient
withdrawn
/off study
Patient in
follow up
Index
Definition
Research Study Code
Clinical Trial Code
(H)
Patient’s medical
records can be
used in research
SNOMED - 873791000000106 | Consent given to
review medical record in research study (finding) |
CTV3 - XaaGz | Consent given to review medical
record in research study |
Read V2 - 9QM.. | Consent given to review medical
record in research study |
SNOMED - 873811000000107 | Consent given to
review medical record in clinical trial (finding) |
CTV3 - XaaH0 | Consent given to review medical
record in clinical trial |
Read V2 - 9PE.. | Consent given to review medical
record in clinical trial |
(I)
Patient actively
participating in the
study (e.g.
attended first
assessment and
continues
participating)
SNOMED - 838621000000107 | Participant in
research study (finding) |
CTV3 - XaZNM | Participant in research study |
Read V2 - 9QC.. | Participant in research study |
SNOMED - 185923000 | Patient entered into trial
(finding) |
CTV3 - 9P11. | Patient entered into trial |
Read V2 - 9P11. | Patient entered into trial |
(J)
Patient withdrawn
from the study –
no longer
participating
SNOMED - 871401000000109 | Withdrawn from
research study (finding) |
CTV3 - XaaDd | Withdrawn from research study |
Read V2 - 9QD.. | Withdrawn from research study |
SNOMED - 185924006 | Patient withdrawn from
trial (finding) |
CTV3 - 9P12. | Patient withdrawn from trial |
Read V2 - 9P12. | Patient withdrawn from trial |
(K)
Patient in followup stage
SNOMED - 871421000000100 | Research study
follow-up (procedure) |
CTV3 - XaaDe | Research study follow-up |
Read V2 - 9QE.. | Research study follow-up |
SNOMED - 24171000000106 | Clinical drug trial
follow up visit (finding) |
CTV3 - XaFrY | Clinical drug trial follow up visit |
Read V2 - 9P3.. | Clinical drug trial follow up visit |
15
Requirement
Patient
completed
/off study
Patient lost
to follow-up
Patient
clinical
assessment
performed
Index
Definition
Research Study Code
Clinical Trial Code
(L)
Patient completed
all the
assessments for
the study
SNOMED - 871441000000107 | Participation in
research study completed (finding) |
CTV3 - XaaDf | Participation in research study
completed |
Read V2 - 9QF.. | Participation in research study
completed |
SNOMED - 443729008 | Completion of clinical trial
(finding) |
CTV3 - XaQHX | Completed clinical trial |
Read V2 - 9P5.. | Completed clinical trial |
(M)
Patient moved
practices/changed
address while on
the study – cannot
be tracked by the
study team and/or
GP
SNOMED - 871461000000108 | Lost to research
study follow-up (finding) |
CTV3 - XaaDg | Lost to research study follow-up |
Read V2 - 9QG.. | Lost to research study follow-up |
SNOMED - 873211000000106 | Lost to clinical trial
follow-up (finding) |
CTV3 - XaaFm | Lost to clinical trial follow-up |
Read V2 - 9PB.. | Lost to clinical trial follow-up |
Procedure/ test/
consultation as a
part of the study
SNOMED - 873241000000107 | Research study
observation activity (regime/therapy) |
CTV3 - XaaFt | Research study observation activity |
Read V2 - 8AE.. | Research study observation
activity |
SNOMED - 873261000000108 | Clinical trial
observation activity (regime/therapy) |
CTV3 - XaaFv | Clinical trial observation activity |
Read V2 - 8AE0. | Clinical trial observation activity
|
(N)
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NIHR Clinical Research Network
National Specialty Hub
King’s College London
Addison House
London,SE1 1UL
Tel: 020 7848 8370
Email:[email protected]
Web: www.crn.nihr.ac.uk
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