Research Codes for Primary Care - NIHR

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Clinical Research Network Primary Care

Research Codes for Primary Care Version 3, July 2017

Table of Contents

Introduction

2

Background

2

New terms explained/patient’s pathway through a study

4

How to use the codes in practice

9 12

Frequently asked questions? What if I don’t know the CPMS ID?

12

How do I know whether to use the codes for a “research study”, or those for a “clinical trial”? 12 When would I use ‘Consented to medical record review’ code?

12 12

Appendix 1: Complete list of codes

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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 outlined below. 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 in the UK, making patient follow-up easy. 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 research activity recorded in the patient record is easy 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 easy process and improving data quality. 2

Benefits for the NIHR CRN ●







Aids the 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 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 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 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 easily. This helps with: providing research data to research teams, increasing data accuracy and for speedier data returns. Specific research codes for individual study activities will be required for these purposes. Tracking patients Research codes will allow tracking of patients participating in specific studies making follow up simpler. 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. Further work is underway to establish whether the use of a generic research template might be beneficial. The NIHR CRN provides support to high-quality clinical research studies. All the studies supported 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 will be 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 (as code values) to enable NHS staff to code research and link it to a specific study. This guidance document outlines how these codes may be used in practice. 3

3. New terms explained/patient’s pathway through a study The code terms outlined below should be used when coding research activities taking place on the site. The list below is a simplified version containing the terms, their definition and examples of when they can be used. The full list of the new codes depending on the practice system being used 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. The study team is responsible for the decision as to which set of codes is used to ensure consistency in coding. 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)

Consent to participate (G) / Consent to medical record review (H)

Participating (I)

Clinical Assessment Performed (N) Follow-up (K)

Withdrawn (J) / Lost to follow-up (M)

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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

Example of when it may be used

This code should be used when 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.

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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)

Research study – invited

Research study – referred

Research study – declined

Research study – consent to participate given

Research study – consented to medical record review

(D)

Invitation to participate in research study

Patient invited to take part in the study (e.g. invitation letter sent)

This code may be used when the patient is provided with information about a study. This may be via a letter of invitation sent by 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)

(E)

Referral for participation in research study

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)

(F)

Declined invitation to participate in research study

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)

(G)

Consent given to participate in research study

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)

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)

(H)

Consent given to review medical record in research study

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Research study – participating/on study

Research study – withdrawn/off study

Research study – in follow up

Research study – completed/off study

(I)

(J)

Participant in research study

Withdrawn from research study

(K)

Research study follow-up

(L)

Participation in research study completed

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 wants 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 the 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)

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)

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Research study – lost to follow-up

(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

Research study – clinical assessment performed

(N)

Research study observation activity

Procedure/test/consultation as a part of the study

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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) 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.

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 link the patient to a 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.

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The study team will inform the GP of those patients who agree to take part.

Practice to update patient record and add code: 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 sees 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 the next 3 months. Each visit will consist of blood pressure, questionnaire and medication compliance check. During the last visit only patient will also have a ECG. No further patient visits but study team requires GP to fax medical notes review data 6 months after data 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 the survival status after 2 years on all their patients who were recruited in study Y. If they are alive after 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 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 many 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 distinguish whether I should 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 used to record research activity for a specific study should be specified in the study protocol and in the information provided to the 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 should 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

Requiremen t

Index

Definition

(A)

Patient screened

(B)

Patient potentially eligible for the study (e.g. record flagged by a MIQUEST query)

(C)

Patient invited

(D)

Patient invited to take part in the study (e.g. invitation letter sent)

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 |

SNOMED - 871271000000102 | Invitation to participate in research study (procedure) | CTV3 - XaaDW | 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

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Patient referred

Patient declined

Patient consent to participate given

Patient consented to medical record review

(E)

(F)

(G)

(H)

Read V2 - 9Q9.. | Invitation to participate in research study |

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 |

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 |

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Patient participatin g/on study

Patient withdrawn /off study

Patient in follow up

Patient completed /off study

Patient lost to follow-up

(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 |

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 |

(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/change d address while on the study – cannot be

SNOMED - 871461000000108 | Lost to research study follow-up (finding) | CTV3 - XaaDg | Lost to research study followup | Read V2 - 9QG.. | Lost to research study

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 |

(K)

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tracked by the study team and/or GP

Patient clinical assessment performed

(N)

Procedure/ test/ consultation as a part of the study

follow-up |

SNOMED - 873241000000107 | Research study observation activity (regime/therapy) | CTV3 - XaaFt | Research study observation activity | Read V2 - 8AE.. | Research study observation activity |

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SNOMED - 873261000000108 | Clinical trial observation activity (regime/therapy) | CTV3 - XaaFv | Clinical trial observation activity | Read V2 - 8AE0. | Clinical trial observation activity |

NIHR Clinical Research Network King’s College London Addison House London, SE1 1UL Tel: 020 7848 8370 Email: [email protected] Web: www.nihr.ac.uk

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