Recording of ’COVID-19 vaccine declined‘: a cohort study on 57.9 million National Health Service patients’ records in situ using OpenSAFELY, England, 8 December 2020 to 25 May 2021
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Abstract
Priority patients in England were offered COVID-19 vaccination by mid-April 2021. Codes in clinical record systems can denote the vaccine being declined.
Aim
We describe records of COVID-19 vaccines being declined, according to clinical and demographic factors.
Methods
With the approval of NHS England, we conducted a retrospective cohort study between 8 December 2020 and 25 May 2021 with primary care records for 57.9 million patients using OpenSAFELY, a secure health analytics platform. COVID-19 vaccination priority patients were those aged ≥ 50 years or ≥ 16 years clinically extremely vulnerable (CEV) or ’at risk’. We describe the proportion recorded as declining vaccination for each group and stratified by clinical and demographic subgroups, subsequent vaccination and distribution of clinical code usage across general practices.
Results
Of 24.5 million priority patients, 663,033 (2.7%) had a decline recorded, while 2,155,076 (8.8%) had neither a vaccine nor decline recorded. Those recorded as declining, who were subsequently vaccinated (n = 125,587; 18.9%) were overrepresented in the South Asian population (32.3% vs 22.8% for other ethnicities aged ≥ 65 years). The proportion of declining unvaccinated patients was highest in CEV (3.3%), varied strongly with ethnicity (black 15.3%, South Asian 5.6%, white 1.5% for ≥ 80 years) and correlated positively with increasing deprivation.
Conclusions
Clinical codes indicative of COVID-19 vaccinations being declined are commonly used in England, but substantially more common among black and South Asian people, and in more deprived areas. Qualitative research is needed to determine typical reasons for recorded declines, including to what extent they reflect patients actively declining.
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SciScore for 10.1101/2021.08.05.21259863: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable We made a small modification to the pregnancy flag, restricting this to females aged under 50, to avoid including any codes incorrectly recorded against males and post-menopausal women. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Priority groups for vaccination: We classified patients into priority groups (box 1) using SNOMED-CT codelists and logic defined in the national COVID-19 Vaccination Uptake Reporting Specification developed by PRIMIS v1.1 (“COVID-19 Vaccination Uptake Reporting Specification” n.d.). PRIMISsuggested: NoneSoftware and Reproducibility: Data … SciScore for 10.1101/2021.08.05.21259863: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable We made a small modification to the pregnancy flag, restricting this to females aged under 50, to avoid including any codes incorrectly recorded against males and post-menopausal women. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Priority groups for vaccination: We classified patients into priority groups (box 1) using SNOMED-CT codelists and logic defined in the national COVID-19 Vaccination Uptake Reporting Specification developed by PRIMIS v1.1 (“COVID-19 Vaccination Uptake Reporting Specification” n.d.). PRIMISsuggested: NoneSoftware and Reproducibility: Data management and analysis was performed using the OpenSAFELY software libraries and Python, both implemented using Python 3. Pythonsuggested: (IPython, RRID:SCR_001658)This analysis was delivered using federated analysis through the OpenSAFELY platform: codelists and code for data management and data analysis were specified once using the OpenSAFELY tools; then transmitted securely to the OpenSAFELY-TPP platform within TPP’s secure environment, and separately to the OpenSAFELY-EMIS platform within EMIS’s secure environment, where they were each executed separately against local patient data; summary results were then reviewed for disclosiveness, released, and combined for the final outputs. EMIS’ssuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Strengths and weaknesses: The key strength of this study is its unprecedented scale: our source population includes 57.9 million people, over 95% of the population in England. This was achieved by developing and deploying data management and data analysis software inside the EHR vendors’ infrastructure, where the patient data already resides. Another key strength is that we identified patients in JCVI priority groups by directly implementing the full official SNOMED-CT codelists and logic for the national PRIMIS COVID-19 Vaccination Uptake Reporting Specification, thus ensuring that our cohorts are perfectly in line with national procedures and GP expectations. We recognise some limitations with our analysis. Our population, though extremely large, may not be fully representative of the full eligible population: it does not include individuals not registered with a general practice, or the 4% of patients registered at practices not using TPP or EMIS. We include only currently registered and living patients, and exclude those who have moved away or died during the vaccination campaign. Primary care records, whilst detailed and longitudinal, cannot be used to determine vaccine eligibility through reasons of employment, and as such our priority groups which include working-age people will have a subset who were offered the vaccination earlier than others. As there is no national guidance on the use of decline codes it is likely that there is variation in how these codes are bein...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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