Disease modifying anti-rheumatic drug (DMARD) therapy monitoring and evaluation of patient progress as part of standard clinical care in rheumatology patients

The rheumatology department at the Oxford University Hospitals NHS Foundation Trust (OUH) did not have an electronic monitoring system to assist in reviewing blood results. Approximately 50-100 patients start a DMARD every month and the team have to ensure that the blood results remain within acceptable limits, in accordance with British Society for Rheumatology guidelines on monitoring disease modifying drug therapy (Ledingham et al 2017).

Situation

The OUH rheumatology department needs to initiate and monitor patients commencing/escalating DMARD therapy (approximately 20-50 patients per week) for the first 3 months, in order to identify who has side effects and also if patients are responding to treatment. If the patient is in difficulty, their therapy may need to be changed or stopped, and an appointment may need to be arranged.

This generates a need to review 200- 500 sets of blood results per week, before patients are discharged to the primary care team. The OUH team had been using a manual method to look for abnormalities individually and with the use of a spreadsheet, but both methods were prone to error (3 abnormal results missed in 2021 with no clinical harm). This is due to the acceptable limits for continuing DMARD are not the same as simply out of range of the “normal” limits.

Aspiration

The project has two overlapping parts: monitoring (of blood results) and evaluation (direct patient reports of any problems encountered in using the DMARD):

• to use computer algorithms to identify which patients starting/escalating a DMARD might have toxicity based on their blood monitoring results
• to provide evidence that patients were tolerating and/or responding to starting/escalating a DMARD by using remote technology to substitute for clinic assessments

Solution and impact

The OUH team used existing licensed software (Microsoft Forms, Microsoft Excel and Microsoft Access) and the electronic patient record (EPR) to design two purpose-built systems (a monitoring system and an evaluation system). This enables the clinicians to rapidly review the blood results of a large number of patients accurately and efficiently to ensure safe use of disease modifying anti-rheumatic drugs.

The team identify patients starting/escalating a DMARD using a Microsoft Form, which is also used to document all of the consultations. They check all patients who have had the DMARD monitoring care set requested in the hospital records system. From this the team compile a weekly list of patients which is sent to the laboratory.

For monitoring, the laboratory sends the results through in weekly batches and loads this into rheumatology assessment database innovation in Oxford (RhADIO) for data processing. The system automatically assesses the values and compare them with acceptable ranges for these medications and grouped them into 5 categories: (normal, mildly abnormal, trending abnormal, missing or abnormal). It also flags patients who had not had their blood test within a certain time frame (required for safe monitoring). A clinician reviews the categories to make clinical decisions and endorse the records in the system. Decisions could involve advising patients to stop their medication, for patients to attend another blood test or for further review.

For evaluation, the team collect clinically relevant information using Microsoft forms, which patients completed using a smart phone, tablet or computer. A link is sent via secure email or text approximately 5-6 weeks after commencing/escalating a DMARD. The information collected enables secondary care clinicians to decide if the patient should continue the DMARD, and if the responsibility for prescribing and monitoring should be transferred to the GP.

Impact

In 2020-21, rheumatology blood monitoring for initiating DMARDs was significantly delayed using a manual method with a single whole-time pharmacist.

• Rheumatology blood monitoring is now up to date with influx of new sets of results of 200-250 per week.
• Over 6500 sets of blood results have been analysed.
• All results are processed in 4 hours per week session by a single clinician trained to operate the system (approx. 90% reduction in manpower).
• The respiratory team will be using the system adapted for their patient cohort on anti-fibrotic therapy.
• The handover system has allowed the team to transfer responsibilities for prescribing and monitoring DMARDs in 69% of 419 patient; a further 14.9% of patients were identified as having not started their therapy.

Functionality

• There are 2 Microsoft Forms, one for clinicians and one for patients. A link is sent through a secure NHS net account as an email or SMS text.
• Forms can be completed on an smartphone, tablet or computer.
• Patient forms contain optional feedback questions.
• All data is stored on a secure hospital server.
• Analyse blood results and group them into normal, mildly abnormal, missing values, trending towards abnormal (compared to the previous result) or abnormal.
• Ability to detect if patients had not attended blood tests at the expected time.
• Synthesise a summary per patient that clinicians could rapidly use to complete their assessment of patients and document this in a semi-automatically produced report.
• EPRs contain bespoke clinic templates to allow reports to be sent quickly to patients and GPs through the standard hospital system.

Capabilities

• Rapidly process information regarding a patient’s blood results in response to starting the new drug or new dose of drug, based on an automated, algorithm-based evaluation of a large amount of data submitted for review at least weekly to detect any early warning signs of toxicity.
• Rapidly process information regarding a patient’s experiences since starting the new drug or new dose of drug.
• Communicate a summary report to the patient and GP outlining any changes in treatment or blood testing. This can include arrangement of a follow up assessment, or a handover of responsibility to the GP for prescribing and monitoring the therapy, in the absence of any toxicity.
• Record all processes to audit the performance.
• Patients to feedback on the process.

Scope

• Patients can complete their form at home.
• All patients who are already known to the rheumatology service are eligible.

Key learning points

• For monitoring of blood results, the OUH team relied on a manual system that was prone to error and resulted in 3 instances of missed abnormal results in 2021.
• Close collaboration with laboratory colleagues was vital.
• THE OUH team validated the monitoring process and demonstrated that the system could perform the analysis more accurately than a manual approach and almost instantaneously allocate results into the appropriate categories (normal, mildly abnormal, trending abnormal, missing or abnormal) to allow clinicians to review the results and focus attention on abnormal and missing results.
• The team have continued to manually check 10% of results and find the automated system accurately categorises the results.
• For evaluation, a few patients who have tried out the forms provided very supportive feedback.
• Some patients were unwilling to complete the form.

Digital equalities

• A phone service is offered to ensure that advice can continue to be provided for all patients who need support.
• Patients who do not submit an MS Form continue to be managed in the traditional pathway.

Key figures

• In 2020/21 rheumatology blood monitoring for initiating DMARDs was significantly delayed using a manual method with a single whole-time pharmacist.
• Rheumatology blood monitoring is now up to date with influx of new sets of results of 200-250 per week.
• Over 6500 sets of blood results analysed: 46% were normal, 12.6% were mildly out of range, 30% showed trends towards abnormality; action was required in 7.3% due to abnormal values or missing values.
• Any actions required can be readily documented in the system and pasted into the EPR.
• All results are processed in one 4-hour session by a single clinician (approx. 90% reduction in manpower).
• The respiratory team will be using the system adapted for their patient cohort on anti-fibrotic therapy.
• Of the first 419 patients reviewed, 69% were handed over to the GPs using the system; a further 14.9% were identified as having not yet started their therapy.

Key contact

Professor Raashid Luqmani, Professor of Rheumatology, Consultant Rheumatologist, Clinical Lead in Rheumatology, University of Oxford

raashid.luqmani@ouh.nhs.uk

Dr Anushka Soni, Consultant Rheumatologist, University of Oxford

anushka.soni@ndorms.ox.ac.uk

David Lang, Rheumatology Pharmacist Oxford University Hospitals NHS Trust

david.lang1@ouh.nhs.uk