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 runn...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e061574.full |
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| author | Jeremy Horwood Alastair D Hay Patricia Jane Lucas Clare Clement Peter S Blair Jodi Taylor Christie Cabral Martin C Gulliford Jenny Ingram Padraig Dixon Nick Francis Athene Lane Grace Young Elizabeth Beech Penny Seume Scott Bevan Sam T Creavin |
| author_facet | Jeremy Horwood Alastair D Hay Patricia Jane Lucas Clare Clement Peter S Blair Jodi Taylor Christie Cabral Martin C Gulliford Jenny Ingram Padraig Dixon Nick Francis Athene Lane Grace Young Elizabeth Beech Penny Seume Scott Bevan Sam T Creavin |
| author_sort | Jeremy Horwood |
| collection | DOAJ |
| description | 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.Trial registration number ISRCTN11405239. |
| format | Article |
| id | doaj-art-474641ed5f7240da892c7b579ac8b83c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-474641ed5f7240da892c7b579ac8b83c2025-01-30T16:55:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-061574Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England?Jeremy Horwood0Alastair D Hay1Patricia Jane Lucas2Clare Clement3Peter S Blair4Jodi Taylor5Christie Cabral6Martin C Gulliford7Jenny Ingram8Padraig Dixon9Nick Francis10Athene Lane11Grace Young12Elizabeth Beech13Penny Seume14Scott Bevan15Sam T Creavin161 Population Health Sciences, Bristol Medical School, Bristol, Bristol, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKSchool for Policy Studies, University of Bristol, Bristol, UK2 University of the West of England, Bristol, UKCentre for Academic Child Health, University of Bristol, Bristol, UKBristol Trials Centre (Bristol Randomised Trial Collaboration), Bristol Medical School, University of Bristol, University of Bristol, Bristol, Avon, UKCentre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UKKing`s College London, London, UKCentre for Academic Child Health, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UKOxford University, Oxford, UK2 Primary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UKPopulation Health Sciences, University of Bristol Medical School, Bristol, UKBristol Trials Centre, University of Bristol, Bristol, UKNHS England, London, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKBristol Trials Centre, University of Bristol, Bristol, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKObjectives 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.Trial registration number ISRCTN11405239.https://bmjopen.bmj.com/content/12/7/e061574.full |
| spellingShingle | Jeremy Horwood Alastair D Hay Patricia Jane Lucas Clare Clement Peter S Blair Jodi Taylor Christie Cabral Martin C Gulliford Jenny Ingram Padraig Dixon Nick Francis Athene Lane Grace Young Elizabeth Beech Penny Seume Scott Bevan Sam T Creavin Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England? BMJ Open |
| title | Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England? |
| title_full | Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England? |
| title_fullStr | Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England? |
| title_full_unstemmed | Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England? |
| title_short | Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England? |
| title_sort | can primary care research be conducted more efficiently using routinely reported practice level data a cluster randomised controlled trial conducted in england |
| url | https://bmjopen.bmj.com/content/12/7/e061574.full |
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