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Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England?

Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England?
Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England?

Objectives: conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients' notes is costly and time-consuming. We investigated barriers and facilitators to running a more efficient design. 

Design: an RCT aiming to reduce antibiotic prescribing among children presenting with acute cough and a respiratory tract infection (RTI) with a clinician-focused intervention, embedded at the practice level. By using aggregate level, routinely collected data for the coprimary outcomes, we removed the need to recruit individual participants. Setting Primary care. 

Participants: baseline data from general practitioner practices and interviews with individuals from Clinical Research Networks (CRNs) in England who helped recruit practices and Clinical Commission Groups (CCGs) who collected outcome data. Intervention The intervention included: (1) explicit elicitation of parental concerns, (2) a prognostic algorithm to identify children at low risk of hospitalisation and (3) provision of a printout for carers including safety-netting advice. Coprimary outcomes For 0-9 years old - (1) Dispensing data for amoxicillin and macrolide antibiotics and (2) hospital admission rate for RTI. 

Results: we recruited 294 of the intended 310 practices (95%) representing 336 496 registered 0-9 years old (5% of all 0-9 years old children). Included practices were slightly larger, had slightly lower baseline prescribing rates and were located in more deprived areas reflecting the national distribution. Engagement with CCGs and their understanding of their role in this research was variable. Engagement with CRNs and installation of the intervention was straight-forward although the impact of updates to practice IT systems and lack of familiarity required extended support in some practices. Data on the coprimary outcomes were almost 100%. 

Conclusions: the infrastructure for trials at the practice level using routinely collected data for primary outcomes is viable in England and should be promoted for primary care research where appropriate.

2044-6055
Blair, Peter S.
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Ingram, Jenny
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Clement, Clare
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Young, Grace
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Seume, Penny
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Taylor, Jodi
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Cabral, Christie
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Lucas, Patricia Jane
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Beech, Elizabeth
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Horwood, Jeremy
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Dixon, Padraig
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Gulliford, Martin C.
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Francis, Nick
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Creavin, Sam T.
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Lane, Athene
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Bevan, Scott
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Hay, Alastair D.
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Blair, Peter S.
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Ingram, Jenny
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Clement, Clare
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Young, Grace
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Seume, Penny
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Taylor, Jodi
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Cabral, Christie
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Lucas, Patricia Jane
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Beech, Elizabeth
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Horwood, Jeremy
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Dixon, Padraig
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Gulliford, Martin C.
5c557aa2-db12-43a2-8778-eac74cf42138
Francis, Nick
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Creavin, Sam T.
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Lane, Athene
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Bevan, Scott
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Hay, Alastair D.
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Blair, Peter S., Ingram, Jenny, Clement, Clare, Young, Grace, Seume, Penny, Taylor, Jodi, Cabral, Christie, Lucas, Patricia Jane, Beech, Elizabeth, Horwood, Jeremy, Dixon, Padraig, Gulliford, Martin C., Francis, Nick, Creavin, Sam T., Lane, Athene, Bevan, Scott and Hay, Alastair D. (2022) Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England? BMJ Open, 12 (7), [e061574]. (doi:10.1136/bmjopen-2022-061574).

Record type: Article

Abstract

Objectives: conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients' notes is costly and time-consuming. We investigated barriers and facilitators to running a more efficient design. 

Design: an RCT aiming to reduce antibiotic prescribing among children presenting with acute cough and a respiratory tract infection (RTI) with a clinician-focused intervention, embedded at the practice level. By using aggregate level, routinely collected data for the coprimary outcomes, we removed the need to recruit individual participants. Setting Primary care. 

Participants: baseline data from general practitioner practices and interviews with individuals from Clinical Research Networks (CRNs) in England who helped recruit practices and Clinical Commission Groups (CCGs) who collected outcome data. Intervention The intervention included: (1) explicit elicitation of parental concerns, (2) a prognostic algorithm to identify children at low risk of hospitalisation and (3) provision of a printout for carers including safety-netting advice. Coprimary outcomes For 0-9 years old - (1) Dispensing data for amoxicillin and macrolide antibiotics and (2) hospital admission rate for RTI. 

Results: we recruited 294 of the intended 310 practices (95%) representing 336 496 registered 0-9 years old (5% of all 0-9 years old children). Included practices were slightly larger, had slightly lower baseline prescribing rates and were located in more deprived areas reflecting the national distribution. Engagement with CCGs and their understanding of their role in this research was variable. Engagement with CRNs and installation of the intervention was straight-forward although the impact of updates to practice IT systems and lack of familiarity required extended support in some practices. Data on the coprimary outcomes were almost 100%. 

Conclusions: the infrastructure for trials at the practice level using routinely collected data for primary outcomes is viable in England and should be promoted for primary care research where appropriate.

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Published date: 1 July 2022

Identifiers

Local EPrints ID: 470895
URI: http://eprints.soton.ac.uk/id/eprint/470895
ISSN: 2044-6055
PURE UUID: f89726e9-9c61-4a9b-98aa-766b3fd927d5
ORCID for Nick Francis: ORCID iD orcid.org/0000-0001-8939-7312

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Date deposited: 20 Oct 2022 16:50
Last modified: 21 Oct 2022 01:56

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Contributors

Author: Peter S. Blair
Author: Jenny Ingram
Author: Clare Clement
Author: Grace Young
Author: Penny Seume
Author: Jodi Taylor
Author: Christie Cabral
Author: Patricia Jane Lucas
Author: Elizabeth Beech
Author: Jeremy Horwood
Author: Padraig Dixon
Author: Martin C. Gulliford
Author: Nick Francis ORCID iD
Author: Sam T. Creavin
Author: Athene Lane
Author: Scott Bevan
Author: Alastair D. Hay

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