Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care
Background The use of anonymised routine linked data in designing and conducting randomised controlled trials (RCTs) has great potential. Sample sizes can be large, inclusion rates high and follow up periods prolonged, while the disruption to participants’ usual routines may be minimised. However, c...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Swansea University
2019-11-01
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| Series: | International Journal of Population Data Science |
| Online Access: | https://ijpds.org/article/view/1250 |
| _version_ | 1797426281490415616 |
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| author | Helen Snooks Alan Watkins Matthew Jones Ashrafunessa Khanom Jenna Jones Ronan A Lyons |
| author_facet | Helen Snooks Alan Watkins Matthew Jones Ashrafunessa Khanom Jenna Jones Ronan A Lyons |
| author_sort | Helen Snooks |
| collection | DOAJ |
| description | Background
The use of anonymised routine linked data in designing and conducting randomised controlled trials (RCTs) has great potential. Sample sizes can be large, inclusion rates high and follow up periods prolonged, while the disruption to participants’ usual routines may be minimised. However, challenges and limitations in using routine linked data in RCTs remain.
Aims
To describe, in primary and emergency settings, challenges and opportunities associated with designing and conducting RCTs using anonymised linked routine data to identify study participants and gather outcomes.
Methods
In each of these trials we have used routine linked data as a key part of the research study design:
PRISMATIC (a stepped wedge trial of predictive risk stratification in primary care) utilised linked data outcomes related to emergency admissions to hospital, GP activity and outpatient appointments. Outcomes were included for 230,000 people registered to participating GP practices in the Swansea area
SAFER 2: a cluster randomised trial of referral to falls services by ambulance paramedics included linked data outcomes related to subsequent emergency episodes for 4,655 patients across three UK regions
TIME: feasibility trial of Take Home Naloxone randomised by city; routine linked data used to identify population for inclusion in follow up and outcomes
Regulatory processes - ethics, research and information governance permissions - have caused delay in each trial; inclusion rates have been much higher than is usual in RCTs (outcomes for >80% of eligible patients); large trials have been achievable at reasonable cost (each trial <£2,000,000). Questions remain about differences between self reported and routinely available outcomes; and between routine data outcomes collected prospectively and through the anonymised linked route.
Conclusion
There are clear benefits in using anonymised linked data outcomes in trials but further research is required to understand costs and limitations. |
| first_indexed | 2024-03-09T08:28:02Z |
| format | Article |
| id | doaj.art-b9c4481fb13649689371a27d7163c01e |
| institution | Directory Open Access Journal |
| issn | 2399-4908 |
| language | English |
| last_indexed | 2024-03-09T08:28:02Z |
| publishDate | 2019-11-01 |
| publisher | Swansea University |
| record_format | Article |
| series | International Journal of Population Data Science |
| spelling | doaj.art-b9c4481fb13649689371a27d7163c01e2023-12-02T20:47:40ZengSwansea UniversityInternational Journal of Population Data Science2399-49082019-11-014310.23889/ijpds.v4i3.1250Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency careHelen Snooks0Alan Watkins1Matthew Jones2Ashrafunessa Khanom3Jenna Jones4Ronan A Lyons5Swansea UniversitySwansea UniversitySwansea UniversitySwansea UniversitySwansea UniversitySwansea UniversityBackground The use of anonymised routine linked data in designing and conducting randomised controlled trials (RCTs) has great potential. Sample sizes can be large, inclusion rates high and follow up periods prolonged, while the disruption to participants’ usual routines may be minimised. However, challenges and limitations in using routine linked data in RCTs remain. Aims To describe, in primary and emergency settings, challenges and opportunities associated with designing and conducting RCTs using anonymised linked routine data to identify study participants and gather outcomes. Methods In each of these trials we have used routine linked data as a key part of the research study design: PRISMATIC (a stepped wedge trial of predictive risk stratification in primary care) utilised linked data outcomes related to emergency admissions to hospital, GP activity and outpatient appointments. Outcomes were included for 230,000 people registered to participating GP practices in the Swansea area SAFER 2: a cluster randomised trial of referral to falls services by ambulance paramedics included linked data outcomes related to subsequent emergency episodes for 4,655 patients across three UK regions TIME: feasibility trial of Take Home Naloxone randomised by city; routine linked data used to identify population for inclusion in follow up and outcomes Regulatory processes - ethics, research and information governance permissions - have caused delay in each trial; inclusion rates have been much higher than is usual in RCTs (outcomes for >80% of eligible patients); large trials have been achievable at reasonable cost (each trial <£2,000,000). Questions remain about differences between self reported and routinely available outcomes; and between routine data outcomes collected prospectively and through the anonymised linked route. Conclusion There are clear benefits in using anonymised linked data outcomes in trials but further research is required to understand costs and limitations.https://ijpds.org/article/view/1250 |
| spellingShingle | Helen Snooks Alan Watkins Matthew Jones Ashrafunessa Khanom Jenna Jones Ronan A Lyons Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care International Journal of Population Data Science |
| title | Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care |
| title_full | Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care |
| title_fullStr | Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care |
| title_full_unstemmed | Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care |
| title_short | Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care |
| title_sort | pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare experience in primary and emergency care |
| url | https://ijpds.org/article/view/1250 |
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