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The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial

Vikki Wylde, Wendy Bertram, Emily Sanderson, Sian Noble, Nicholas Howells, Tim J Peters, Andrew D Beswick, Ashley W Blom, Andrew J Moore, Julie Bruce, David A Walsh, Christopher Eccleston, Shaun Harris Orcid Logo, Kirsty Garfield, Simon White, Andrew Toms, Rachael Gooberman-Hill, Amanda Burston, Jane Dennis, Paul Dieppe, Benjamin Burston, Vikram Desai, Tim Board, Colin Esler, Michael Parry, Jonathan R.A. Phillips

The Lancet Rheumatology, Volume: 4, Issue: 3, Pages: e188 - e197

Swansea University Author: Shaun Harris Orcid Logo

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DOI (Published version): 10.1016/s2665-9913(21)00371-4

Abstract

BackgroundApproximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement.MethodsWe did an unmasked...

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Published in: The Lancet Rheumatology
ISSN: 2665-9913
Published: Elsevier BV 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa61368
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We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement.MethodsWe did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0&#x2013;10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361.FindingsBetween Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was &#x2212;0&#xB7;65 (95% CI &#x2212;1&#xB7;17 to &#x2212;0&#xB7;13; p=0&#xB7;014) and the mean between-group difference in the BPI interference score was &#x2212;0&#xB7;68 (&#x2212;1&#xB7;29 to &#x2212;0&#xB7;08; p=0&#xB7;026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of &#xA3;1256 (95% CI 164 to 2348) at &#xA3;20&#x2009;000 per QALY threshold. 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spelling 2022-10-11T10:45:56.5343132 v2 61368 2022-09-27 The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial 10b1bd08dbad1f2681ff1e527af9f9a3 0000-0001-7724-6621 Shaun Harris Shaun Harris true false 2022-09-27 PHAC BackgroundApproximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement.MethodsWe did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0–10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361.FindingsBetween Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was −0·65 (95% CI −1·17 to −0·13; p=0·014) and the mean between-group difference in the BPI interference score was −0·68 (−1·29 to −0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group.InterpretationSTAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. Journal Article The Lancet Rheumatology 4 3 e188 e197 Elsevier BV 2665-9913 1 3 2022 2022-03-01 10.1016/s2665-9913(21)00371-4 COLLEGE NANME Public Health COLLEGE CODE PHAC Swansea University Another institution paid the OA fee 2022-10-11T10:45:56.5343132 2022-09-27T16:31:59.9840623 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Public Health Vikki Wylde 1 Wendy Bertram 2 Emily Sanderson 3 Sian Noble 4 Nicholas Howells 5 Tim J Peters 6 Andrew D Beswick 7 Ashley W Blom 8 Andrew J Moore 9 Julie Bruce 10 David A Walsh 11 Christopher Eccleston 12 Shaun Harris 0000-0001-7724-6621 13 Kirsty Garfield 14 Simon White 15 Andrew Toms 16 Rachael Gooberman-Hill 17 Amanda Burston 18 Jane Dennis 19 Paul Dieppe 20 Benjamin Burston 21 Vikram Desai 22 Tim Board 23 Colin Esler 24 Michael Parry 25 Jonathan R.A. Phillips 26 61368__25401__65c46102ba08446c84fc9254157fdddd.pdf 61368_VoR.pdf 2022-10-11T10:43:25.0165655 Output 641043 application/pdf Version of Record true © 2022 The Author(s). This is an Open Access article under the CC BY 4.0 license true eng https://creativecommons.org/licenses/by/4.0/
title The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial
spellingShingle The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial
Shaun Harris
title_short The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial
title_full The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial
title_fullStr The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial
title_full_unstemmed The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial
title_sort The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial
author_id_str_mv 10b1bd08dbad1f2681ff1e527af9f9a3
author_id_fullname_str_mv 10b1bd08dbad1f2681ff1e527af9f9a3_***_Shaun Harris
author Shaun Harris
author2 Vikki Wylde
Wendy Bertram
Emily Sanderson
Sian Noble
Nicholas Howells
Tim J Peters
Andrew D Beswick
Ashley W Blom
Andrew J Moore
Julie Bruce
David A Walsh
Christopher Eccleston
Shaun Harris
Kirsty Garfield
Simon White
Andrew Toms
Rachael Gooberman-Hill
Amanda Burston
Jane Dennis
Paul Dieppe
Benjamin Burston
Vikram Desai
Tim Board
Colin Esler
Michael Parry
Jonathan R.A. Phillips
format Journal article
container_title The Lancet Rheumatology
container_volume 4
container_issue 3
container_start_page e188
publishDate 2022
institution Swansea University
issn 2665-9913
doi_str_mv 10.1016/s2665-9913(21)00371-4
publisher Elsevier BV
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care - Public Health{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Public Health
document_store_str 1
active_str 0
description BackgroundApproximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement.MethodsWe did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0–10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361.FindingsBetween Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was −0·65 (95% CI −1·17 to −0·13; p=0·014) and the mean between-group difference in the BPI interference score was −0·68 (−1·29 to −0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group.InterpretationSTAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery.
published_date 2022-03-01T04:20:10Z
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